Claudin 18.2 expression

Approved therapies

Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Where we have them, the pivotal trial's results and side effects are shown under each therapy, from the official label. Results from different trials are not directly comparable: patients, earlier treatments and comparators differ.

Companion diagnostic tests

Tests the FDA has approved to select patients for a specific therapy. Other validated tests are often used in practice, especially in Europe.

Drugs in active trials

Targeted drugs, antibody-drug conjugates and immunotherapies in active trials on this page, approved ones first, then by the furthest phase reached. Chemotherapy and supportive medicines are left out. "Not yet classified" means an early drug known only by its code.

25 of 61 drugs shown

Show all 61 drugs

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months: the date the main results are due to be collected, according to the sponsor. Results are usually published months later, and these dates often slip.

Show all 27 readouts

Companies

Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.

1. Astellas 10
2. AstraZeneca 7
3. Innovent Biologics 5
4. Jiangsu Hengrui 4
5. Beijing Biotech 4
6. Antengene Biologics 3
7. Qilu Pharmaceutical 3
8. CARsgen Therapeutics 3
9. SmartNuclide Biopharma 3
10. AskGene Pharma 2
11. FutureGen Biopharmaceutical 2
12. LaNova Medicines Zhejiang 2
13. Transcenta Therapeutics 2
14. I-Mab Biopharma US 2
15. Kelun-Biotech 2

Phase 1 Phase 2 Phase 3 Phase 4 No phase

Trials

Matched automatically from registry text, so a few trials may only mention Claudin 18.2 expression rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

106 of 160 trials shown

1. A Study of Zolbetuximab Given With mFOLFOX6 or CAPOX Chemotherapy in Indian Adults With Gastric Cancer

   Not yet recruiting Phase 4 Astellas Started 2026Primary completion 2029-07 NCT07829757

   zolbetuximab FDA EUoxaliplatinleucovorinfluorouracilcapecitabine

   Participant's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determine…

   Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

2. Combination of Osemitamab (TST001), Pembrolizumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC/GEJ Adenocarcinoma

   Not yet recruiting Phase 3 Transcenta Therapeutics Starts 2027Primary completion 2029-10 NCT06093425

   pembrolizumaboxaliplatinleucovorinfluorouracil

   Positive CLDN18.2 expression in tumor tissue confirmed by the central laboratory at screening using CTA (Cl…

   Gastric Cancer, Gastroesophageal-junction Cancer, Advanced Cancer

3. Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma.

   Recruiting Phase 3 Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Started 2026Primary completion 2028-10 NCT07385703

   LM-302tislelizumaboxaliplatincapecitabine

   After confirmation by the central laboratory, tumor tissue with positive CLDN18.2 expression is defined as ≥25% tumor cell membrane staining intensity 2+ \& 3+.

   Adenocarcinoma

4. A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer

   Recruiting Phase 3 Astellas Started 2026Primary completion 2031-02 NCT07673887

   ASP2138pembrolizumaboxaliplatincapecitabineleucovorinfluorouracil

   Participant has CLDN18.2-positive tumor as determined by central testing.

   Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma

5. JS107 in Combination With Toripalimab and Chemotherapy for the Treatment of CLDN18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

   Recruiting Phase 3 NingBo Junyan Hongshi Biosciences Started 2026Primary completion 2029-01 NCT07584135

   toripalimaboxaliplatincapecitabinesintilimab

   …t, or Metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. 7）Positive for CLDN18.2 by IHC testing at the central laboratory. 8）According to the RECIST v1.1 criteria, the pa…

   Gastric Adenocarcinoma

6. Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2

   Recruiting Phase 3 AstraZeneca Started 2026Primary completion 2029-08 NCT07431281

   AZD0901Rilvegostomignivolumabcapecitabinefluorouraciloxaliplatinzolbetuximab FDA EUleucovorin

   Positive CLDN18.2 expression, as determined prospectively by central IHC testing

   Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer

7. A Study of FG-M108+Chemotherapy vs Placebo+Chemotherapy in Claudin18.2-positive Pancreatic Cancer

   Not yet recruiting Phase 3 FutureGen Biopharmaceutical Started 2026Primary completion 2030-06 NCT07383922

   FG-M108nab-paclitaxelgemcitabine

   …ical tissue for CLDN18.2 testing, with central laboratory testing confirming tumor tissue CLDN18.2 positive (defined as ≥40% of tumor cells with CLDN18.2 membrane staining ≥2+ by central l…

   Pancreatic Cancer

8. A Study of ATG-022 Compared With Investigator's Choice of Treatment in Claudin 18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

   Not yet recruiting Phase 3 Antengene Biologics Started 2026Primary completion 2029-12 NCT07795346

   ATG-022docetaxelirinotecan

   … advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with positive CLDN18.2 expression.

   Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

9. Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma

   Recruiting Phase 3 Federation Francophone de Cancerologie Digestive Started 2025Primary completion 2030-11 NCT07270991

   trifluridine/tipiracilfruquintinib

   …or taxane (+/- anti-HER2 agents +/- immune checkpoint inhibitors +/- ramucirumab +/- anti-claudin 18.2).

   Metastatic Oesogastric Adenocarcinoma

10. A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)

    Recruiting Phase 3 Innovent Biologics Started 2025Primary completion 2027-06 NCT07066098

    IBI343

    Confirmed as CLDN18.2 positive.

    Pancreatic Cancer

11. JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma.

    Recruiting Phase 3 Shanghai Junshi Bioscience Started 2025Primary completion 2027-10 NCT07284134

    JS107 for Injectionirinotecanpaclitaxeldocetaxel

    … \[FFPE\] tissue or unstained FFPE tumor tissue sections) must be available and comfirmed CLDN18.2 positivity by for central laboratory through immunohistochemistry (IHC) before randomizat…

    Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

12. A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer

    Recruiting Phase 3 Astellas Started 2025Primary completion 2028-09 NCT06901531

    zolbetuximab FDA EUpembrolizumabcapecitabineoxaliplatinleucovorinfluorouracil

    Participant's tumor expresses Claudin18.2 (CLDN18.2) in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining a…

    Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

13. A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients

    Recruiting Phase 3 Suzhou Immunofoco Biotechnology Started 2025Primary completion 2027-05 NCT07103668

    CAR T cellsControl

    A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients

    Gastric Adenocarcinoma

14. ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma

    Active, not recruiting Phase 3 AskGene Pharma Started 2024Primary completion 2026-12 NCT06206733

    ASKB589oxaliplatincapecitabinetislelizumab

    CLDN 18.2 positive

    Gastroesophageal Junction Adenocarcinoma, Gastric Adenocarcinoma

15. SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

    Recruiting Phase 3 Jiangsu Hengrui Started 2024Primary completion 2027-09 NCT06649292

    SHR-A1904paclitaxeldocetaxelirinotecan

    6. positive CLDN18.2 expression in tumor tissue;

    Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

16. A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (G-HOPE-001)

    Active, not recruiting Phase 3 Innovent Biologics Started 2024Primary completion 2026-12 NCT06238843

    irinotecanpaclitaxeltrifluridine/tipiracilIBI343

    Has histopathologically confirmed CLDN18.2-positive disease.

    Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

17. LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.

    Active, not recruiting Phase 3 LaNova Medicines Zhejiang Started 2024Primary completion 2026-11 NCT06351020

    LM-302apatinibirinotecan

    Centrally confirmed CLDN18.2-positive

    Locally Advanced or Metastatic GC and GCJ Adenocarcinoma

18. AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

    Active, not recruiting Phase 3 AstraZeneca Started 2024Primary completion 2026-05 NCT06346392

    AZD0901ramucirumabpaclitaxeldocetaxelirinotecantrifluridine/tipiracilapatinib

    (a) Participants with positive CLDN18.2 expression from archival tumor collected within past 24 months or from a fresh biopsy.

    Gastric Cancer, Gastroesophageal Junction Cancer

19. A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).

    Active, not recruiting Phase 3 Astellas Started 2018Primary completion 2022-10 NCT03653507

    zolbetuximab FDA EUoxaliplatincapecitabine

    Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determine…

    Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

20. A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.

    Active, not recruiting Phase 3 Astellas Started 2018Primary completion 2022-09 NCT03504397

    zolbetuximab FDA EUoxaliplatinleucovorinfluorouracil

    Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determine…

    Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

21. Timing of Comprehensive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma

    Recruiting Phase 2 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Started 2026Primary completion 2031-11 NCT07000253

    ChemotherapyTargeted Systemic TherapyImmunotherapy

    Claudin 18.2 overexpression as per local clinical practice for zolbetuximab use.

    Esophageal Cancer, Gastric (Stomach) Cancer, Gastric Adenocarcinoma, Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma

22. Zolbetuximab With mFOLFOX6 or CAPOX in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers

    Not yet recruiting Phase 2 Midhun Malla Started 2026Primary completion 2029-02 NCT07723534

    zolbetuximab FDA EUmFOLFOX6CAPOX

    Expression of Claudin 18.2 (CLDN18.2) in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining a…

    Advanced Biliary Tract Cancer, Metastatic Biliary Tract Carcinoma

23. Dual-Target CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma

    Recruiting Phase 1/2 Beijing Biotech Started 2026Primary completion 2027-04 NCT07627711

    EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1)EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1)fludarabinecyclophosphamide

    …sh biopsy): • Arm A eligibility: MSLN positive and/or MUC1 positive. • Arm B eligibility: CLDN18.2 positive and/or MUC1 positive. (Example threshold: IHC 2+ or 3+ staining in \>=50% of tum…

    Pancreatic Ductal Adenocarcinoma (PDAC), Unresectable Locally Advanced, Metastatic Disease

24. ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer

    Recruiting Phase 1/2 Anova Innovation Started 2026Primary completion 2027-08 NCT07444541

    ANO31905gemcitabinenab-paclitaxelmFOLFIRINOXoxaliplatinirinotecanleucovorinfluorouracil

    Tumor tissue samples are determined to be CLDN18.2-positive by immunohistochemistry (IHC) in the central laboratory, defined as ≥1% of tumor…

    Pancreatic Cancer

25. Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)

    Recruiting Phase 2 I-Mab Biopharma US Started 2026Primary completion 2030-03 NCT07432295

    Givastomignivolumabfluorouracilleucovorinoxaliplatincapecitabine

    CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells).

    Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer

26. Neoadjuvant Tislelizumab + LM-302 + S-1 or Tislelizumab + SOX for CLDN18.2-Positive Gastric/GEJ Adenocarcinoma

    Recruiting Phase 2 Ruijin Hospital Started 2026Primary completion 2028-04 NCT07569068

    tislelizumabLM-302oxaliplatin

    Claudin 18.2 positive (≥25% of tumor cells showing moderate-to-strong membrane staining);

    Gastric or Esophagogastric Junction Adenocarcinoma

27. IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

    Recruiting Phase 2 Innovent Biologics Started 2026Primary completion 2030-06 NCT07483567

    IBI343sintilimaboxaliplatin

    Confirmed CLDN18.2 expression by central laboratory pathological tissue testing.

    CLDN18.2 Positive, Primary Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

28. A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer

    Recruiting Phase 2 Jiangsu Hengrui Started 2026Primary completion 2030-12 NCT07450976

    SHR-A1904

    CLDN18.2 positive expression;

    Biliary Tract Cancer

29. Zolbetuximab, Durvalumab, and FLOT Combination Neoadjuvant Chemotherapy for CLDN18.2-Positive Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

    Recruiting Phase 2 National Cancer Center, Japan Started 2026Primary completion 2030-03 NCT07872722

    zolbetuximab FDA EUdurvalumabfluorouracilleucovorinoxaliplatindocetaxel

    Zolbetuximab, Durvalumab, and FLOT Combination Neoadjuvant Chemotherapy for CLDN18.2-Positive Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

    CLDN18.2-Positive Gastric Cancer, CLDN18.2-Positive Gastroesophageal Junction Adenocarcinoma

30. IBI343 in Combination Therapy for Advanced Malignant Solid Tumors

    Recruiting Phase 2 Innovent Biologics Started 2026Primary completion 2028-03 NCT07483554

    IBI343gemcitabinenab-paclitaxel

    Confirmed CLDN18.2 positive by central laboratory pathological tissue testing.

    CLDN18.2 Positive, Gastric/Gastroesophageal Junction Adenocarcinoma, Pancreatic Ductal Adenocarcinoma

31. A Phase Ib/II Study of ATG-022 Plus Pembrolizumab With/Without Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaUnresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

    Recruiting Phase 1/2 Antengene Biologics Started 2026Primary completion 2027-09 NCT07327229

    ATG-022pembrolizumabCAPOX

    …tological confirmation of gastric cancer or gastroesophageal junction adenocarcinoma with CLDN 18.2 positive, HER2-negative and PD-L1 positive expression.

    Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

32. Dual-Targeting CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma

    Recruiting Phase 1/2 Beijing Biotech Started 2026Primary completion 2027-02 NCT07480928

    EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1)EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1)fludarabinecyclophosphamide

    …sh biopsy): • Arm A eligibility: MSLN positive and/or MUC1 positive. • Arm B eligibility: CLDN18.2 positive and/or MUC1 positive. (Example threshold: IHC 2+ or 3+ staining in \>=50% of tum…

    Pancreatic Ductal Adenocarcinoma (PDAC), Unresectable Locally Advanced or Metastatic Disease

33. A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors

    Recruiting Phase 1/2 Astellas Started 2026Primary completion 2029-07 NCT07488676

    ASP546C

    Participant's tumor expresses CLDN18.2.

    Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma, Pancreatic Adenocarcinoma

34. SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC/ GEJ Adenocarcinoma

    Not yet recruiting Phase 2 Kelun-Biotech Started 2026Primary completion 2028-06 NCT07609667

    tislelizumabSKB315 for injectioncapecitabine

    …r tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 and PD-L1 expression as determined by IHC;

    Gastroesophageal Junction Adenocarcinoma

35. Dual-Target CLDN18.2/HER2 CAR-NK Cells for Advanced Esophageal Adenocarcinoma

    Recruiting Phase 1/2 Beijing Biotech Started 2026Primary completion 2027-03 NCT07622940

    EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cellsfludarabinecyclophosphamide

    Evidence of at least one selected target: CLDN18.2-positive by validated IHC (example threshold: membranous staining in

    Recurrent or Metastatic Esophageal Adenocarcinoma, Biomarker-selected CLDN18.2-positive and/or HER2-positive Disease

36. Phase Ib/IIa Open-label Study, to Evaluate Safety, Tolerability, and Antitumor Activity of HCB101 in Combination With Multiple Agents in Subjects With Advanced Gastric or Gastro-esophageal (GEJ) Adenocarcinoma

    Not yet recruiting Phase 1/2 Kaohsiung Medical University Chung-Ho Memorial Hospital Started 2026Primary completion 2027-12 NCT07680569

    zolbetuximab FDA EUoxaliplatinfluorouracilleucovorinCAPOXcapecitabine

    …y advanced, or metastatic HER2 (-) gastric or GEJ adenocarcinoma cancer, whose tumors are CLDN 18.2 positive (defined as ≥ 75% of tumor cells demonstrating moderate to strong membranous CLD…

    GC/GEJC

37. A Phase I/II Study of FG-M108 Plus FG-B901 in Advanced CLDN18.2-Positive Solid Tumors

    Not yet recruiting Phase 1/2 FutureGen Biopharmaceutical Started 2026Primary completion 2028-08 NCT07704866

    FG-B901FG-M108

    CLDN18.2 positive (defined as ≥10% of tumor cells showing membrane staining ≥1+ by central laborat…

    Claudin 18.2, Solid Tumor Malignancies

38. LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: a Prospective, Exploratory Study

    Recruiting Phase 2 Ruijin Hospital Started 2026Primary completion 2028-04 NCT07556640

    LM-302paclitaxelcadonilimab

    Claudin 18.2 positive (≥ 25%, moderate to strong staining);

    Gastric Cancer Stage IV, Peritoneal Metastases From Gastric Cancer, Gastric or Esophagogastric Junction Adenocarcinoma

39. A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors

    Recruiting Phase 1/2 LigaChem Biosciences Started 2026Primary completion 2030-02 NCT07460375

    LCB02A

    …Dose Escalation: histologically or cytologically confirmed advanced solid tumors that are Claudin 18.2 positive and refractory to standard of care treatment.

    Advanced Solid Tumors

40. Dual-target CLDN18.2/HER2 CAR-NK Cells for Advanced Gastric/GEJ Cancer

    Recruiting Phase 1/2 Beijing Biotech Started 2026Primary completion 2027-03 NCT07551362

    EB-DT-CAR-NKfludarabinecyclophosphamide

    Central confirmation of CLDN18.2-positive disease by immunohistochemistry, defined for this draft as membranous CLDN18.2 e…

    Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma

41. IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer

    Not yet recruiting Phase 2 Zhejiang University Started 2026Primary completion 2028-12 NCT07415525

    IBI343

    (11)Confirmed \*CLDN18.2 positivity by pathological tissue testing. \*CLDN18.2 positivity is defined as Claudin18.…

    Pancreatic Cancer, Borderline Resectable Pancreatic Adenocarcinoma

42. Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping

    Not yet recruiting Phase 2 China Medical University Started 2025Primary completion 2029-08 NCT06881017

    trastuzumabadebrelimabapatinibS-1capecitabineoxaliplatinzolbetuximab FDA EUtrastuzumab rezetecanSHR-A1904SHR-1701

    Archival or fresh tumor tissue sample available for biomarker testing (HER2, CLDN18.2, and PD-L1 expression);

    Gastric Cancer, HER2 + Gastric Cancer, CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, PD-L1 Positive

43. A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma

    Recruiting Phase 2 AstraZeneca Started 2025Primary completion 2027-11 NCT07069712

    AZD0901Rilvegostomigtrastuzumab deruxtecancapecitabinefluorouracilFLOT Chemotherapyleucovorin

    Participants who are CLDN18.2-positive in Sub-study 1 or HER2-positive in Sub-study 2

    Gastroesophageal Adenocarcinoma

44. A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer

    Recruiting Phase 1/2 Asan Medical Center Started 2025Primary completion 2027-12 NCT06732856

    zolbetuximab FDA EUoxaliplatindocetaxelS-1

    Subjects who are CLDN18.2 positive (VENTANA 43-14A ≥75%)

    Stomach Neoplasm, Gastric (Stomach) Cancer

45. IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

    Recruiting Phase 1/2 Zhejiang Cancer Hospital Started 2025Primary completion 2027-06 NCT07692750

    IBI343capecitabineoxaliplatin

    The histopathological test confirmed that \*CLDN18.2 was positive.For subjects who have previously received any anti-CLDN18.2 treatment, tumor…

    Advanced Pancreatic Cancer

46. IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

    Recruiting Phase 2 Zhejiang University Started 2025Primary completion 2027-01 NCT06770439

    IBI343gemcitabinenab-paclitaxel

    Pathological tissue testing was confirmed as CLDN18.2 positive.

    Advanced Pancreatic Cancers

47. Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer

    Recruiting Phase 2 Universitaire Ziekenhuizen KU Leuven Started 2025Primary completion 2029-12 NCT06962137

    zolbetuximab FDA EU

    CLDN18.2-positive (defined as ≥75% of tumour cells showing moderate-to-strong membranous CLDN18.2 …

    Gastric Cancer Adenocarcinoma Metastatic, Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma

48. Study for AZD4360 in Participants With Advanced Solid Tumours

    Active, not recruiting Phase 1/2 AstraZeneca Started 2025Primary completion 2027-03 NCT06921928

    AZD4360

    …phageal junction cancer (G/GEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.

    Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma

49. Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma

    Recruiting Phase 2 UNICANCER Started 2025Primary completion 2027-09 NCT06846346

    ivonescimabFOLFOXoxaliplatinleucovorinfluorouracilirinotecanpaclitaxel

    …east one of the following actionable biomarker (PD-L1 CPS≥1, and/or HER2-positive, and/or Claudin 18.2-positive), who had received only one prior line of treatment for advanced disease (cohort…

    Metastatic Esophageal Adenocarcinoma, Advanced Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Advanced Gastric Adenocarcinoma

50. Mesothelin and Claudin 18.2 Dual-Target CAR-T Therapy in Advanced Pancreatic Cancer

    Recruiting Phase 1/2 Essen Biotech Started 2025Primary completion 2027-12 NCT07066995

    Mesothelin and Claudin 18.2 CAR-T cells

    Mesothelin and Claudin 18.2 Dual-Target CAR-T Therapy in Advanced Pancreatic Cancer

    Pancreatic Cancer, Pancreatic Carcinoma, Pancreatic Cancer Non-resectable, Pancreatic Cancer Stage IV

51. Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer

    Not yet recruiting Phase 2 Qilu Pharmaceutical Started 2025Primary completion 2026-10 NCT07151872

    QLS31905gemcitabinecisplatinQL2107 Injectionoxaliplatincapecitabine

    Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer

    CLDN18.2-positive Advanced Biliary Tract Cancer

52. Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer

    Recruiting Phase 2 Jeeyun Lee Started 2025Primary completion 2028-10 NCT06630130

    trastuzumab deruxtecancapecitabineRilvegostomigdurvalumabSonesitatug Vedotinoxaliplatin

    In Cohort A＆B, HER2 positive (HER2 IHC 3+ or HER2 IHC 2+/ISH positive) In Cohort C＆D, CLDN18.2 positive

    Stomach Neoplasms

53. Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis

    Recruiting Phase 2 Ruijin Hospital Started 2025Primary completion 2027-01 NCT06519591

    cadonilimabLM-302paclitaxel

    Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accou…

    Gastric Cancer Stage IV, Peritoneal Metastases

54. IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

    Recruiting Phase 1/2 Ruijin Hospital Started 2025Primary completion 2027-07 NCT07025889

    IBI343sintilimaboxaliplatinS-1

    Has histopathologically confirmed CLDN18.2-positive disease. 6.

    Gastric Cancer

55. A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2

    Active, not recruiting Phase 2 AstraZeneca Started 2025Primary completion 2026-08 NCT07143604

    AZD0901

    …advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus, with positive CLDN18.2 expression.

    Gastric Cancer, Gastroesophageal Junction Cancer

56. Combination of QLS31905, QL2107 and Chemotherapy as First-line Therapy in CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

    Not yet recruiting Phase 2 Qilu Pharmaceutical Started 2025Primary completion 2026-12 NCT06942767

    QLS31905QL2107 Injectionoxaliplatincapecitabine

    Combination of QLS31905, QL2107 and Chemotherapy as First-line Therapy in CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction…

    Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

57. Efficacy and Safety of LM-302 Combined With Gemcitabine CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer

    Not yet recruiting Phase 2 Shanghai Zhongshan Hospital Started 2025Primary completion 2026-08 NCT07108504

    gemcitabineLM-302

    CLDN18.2 positivity defined as: Moderate-to-high staining intensity (2+\~3+) in ≥50% of tumor cell…

    Pancreatic Cancer, Chemotherapy Effect

58. Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors

    Not yet recruiting Phase 2 Qilu Pharmaceutical Started 2024Primary completion 2026-06 NCT06446388

    QLS31905oxaliplatincapecitabinegemcitabinecisplatiniparomlimab and tuvonralimabChemotherapy drug

    Tumor tissue samples determined to be positive for Claudin18.2 by immunohistochemistry (IHC);

    Status may be outdated, last updated 2024-06-06Advanced Solid Tumor

59. The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

    Recruiting Phase 2 Shanghai Zhongshan Hospital Started 2024Primary completion 2025-07 NCT06587425

    LM-302capecitabinecadonilimab

    CLDN18.2 positivity: Provide sufficient tissue markers for Claudin18.2 immunohistochemistry testin…

    Status may be outdated, last updated 2024-09-19Gastric or Gastroesophageal Junction Adenocarcinoma

60. A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study

    Recruiting Phase 2 LaNova Medicines Zhejiang Started 2023Primary completion 2031-08 NCT05934331

    LM-302toripalimabcapecitabineTegafur, Gimeracil and Oteracil Potassium Capsulesnivolumabapatinibgemcitabinetislelizumabanlotinibbenmelstobart

    CLDN18.2-positive subjects.

    Malignant Neoplasms of Digestive Organs

61. ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer.

    Active, not recruiting Phase 1/2 AskGene Pharma Started 2023Primary completion 2025-10 NCT05632939

    CAPOXsintilimabtislelizumab

    Tumor tissue samples are CLDN18.2 positive detected by central laboratory

    Gastric Cancer, Gastroesophageal Cancer (GC)

62. TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3)

    Active, not recruiting Phase 1/2 Triumvira Immunologics Started 2023Primary completion 2027-08 NCT05862324

    TAC01-CLDN18.2

    Tumor tissue samples positive for CLDN18.2 as assessed by central laboratory.

    Metastatic Solid Tumor

63. Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors

    Recruiting Phase 1/2 AstraZeneca Started 2023Primary completion 2029-03 NCT06005493

    AZD5863AZD2936

    Must show positive CLDN18.2 expression in tumor cells as determined by central immunohistochemistry (IHC)

    Gastric Cancer, Gastro-esophageal Junction Cancer, Pancreatic Ductal Adenocarcinoma, Esophageal Adenocarcinoma

64. Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody

    Active, not recruiting Phase 1/2 Shanghai Zhongshan Hospital Started 2023Primary completion 2026-05 NCT05994001

    cardonilizumabLM-302

    …histologically confirmed, and sufficient tissue specimens are provided for PD-L1, CTLA-4, Claudin18.2 immunohistochemistry and exon sequencing.

    Biliary Tract Cancer, Candonilimab, Claudin 18.2

65. AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

    Recruiting Phase 2 AstraZeneca Started 2023Primary completion 2026-11 NCT06219941

    AZD0901fluorouracilleucovorinirinotecanliposomal irinotecangemcitabine

    Participants who are CLDN18.2 positive.

    Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma

66. XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.

    Active, not recruiting Phase 1/2 Astellas Started 2023Primary completion 2026-12 NCT06792435

    XNW27011

    The enrollment is not restricted to patients with tumor expressing CLDN18.2.

    Pancreatic Adenocarcinoma Metastatic, Lung Cancer (NSCLC), Ovarian Cancer, Colorectal Cancer Metastatic

67. A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

    Recruiting Phase 1/2 RemeGen Started 2022Primary completion 2025-09 NCT05205850

    RC118-ADC

    … junction cancer, pancreatic cancer, ovarian cancer, and cholangiocarcinoma with positive Claudin 18.2 expression (membrane staining is observed in any tumor cells)

    Advanced Solid Tumor

68. A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS

    Recruiting Phase 1/2 Jiangsu Hengrui Started 2022Primary completion 2026-05 NCT05277168

    SHR-A1904

    Positive expression of Claudin 18.2 (\>= 50% of cells with 2+ or 3+ expression, either from fresh or archival tissue) is requ…

    Advanced Solid Tumors

69. A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors

    Active, not recruiting Phase 1/2 Jiangsu Aosaikang Pharmaceutical Started 2021Primary completion 2025-10 NCT04632108

    ASKB589 Injection

    …have no access to standard therapy for various reasons, and that tumor tissue samples are CLDN18.2 positive detected by central laboratory (medium-high expression)；

    Malignant Solid Tumor

70. A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors

    Active, not recruiting Phase 1/2 Transcenta Therapeutics Started 2020Primary completion 2027-06 NCT04495296

    osemitamaboxaliplatincapecitabinepaclitaxelgemcitabinecisplatinnivolumab

    …pansion study: The subjects with positive CDLN18.2 expression in tumor tissue (defined as CLDN18.2 membranous staining ≥1+ in ≥10% of tumor cells by immunohistochemistry (IHC) in the centr…

    Advanced Cancer

71. Claudin18.2 CAR-T (CT041) in Patients With Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers

    Active, not recruiting Phase 1/2 CARsgen Therapeutics Started 2020Primary completion 2025-06 NCT04404595

    satricabtagene autoleucel

    Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay;

    Gastric Cancer, Pancreatic Cancer

72. Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection

    Active, not recruiting Phase 1/2 CARsgen Therapeutics Started 2020Primary completion 2024-10 NCT04581473

    satricabtagene autoleucelpaclitaxelirinotecanapatinib

    Phase Ib：Tumor tissue samples were positive for CLDN18.2 IHC staining； Phase II：Tumor tissue samples were positive for CLDN18.2 IHC staining and H…

    Gastric Adenocarcinoma, Pancreatic Cancer, Gastroesophageal Junction Adenocarcinoma

73. A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer

    Active, not recruiting Phase 2 Astellas Started 2019Primary completion 2026-10 NCT03816163

    zolbetuximab FDA EUnab-paclitaxelgemcitabine

    Subject's tumor sample has CLDN18.2 expression in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining a…

    Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma

74. A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer

    Active, not recruiting Phase 2 Astellas Started 2018Primary completion 2027-06 NCT03505320

    zolbetuximab FDA EUoxaliplatinleucovorinfluorouracilpembrolizumabnivolumabdocetaxel

    Subject's tumor is positive for CLDN18.2 expression demonstrating moderate to strong membranous staining as determined by central …

    Pharmacokinetics of Zolbetuximab, Gastric Cancer, Gastro-esophageal Junction (GEJ) Cancer, Pharmacokinetics of Oxaliplatin

75. A First-In-Human Phase I/IIa Study to Evaluate DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma

    Recruiting Phase 1 Dong-A ST Started 2026Primary completion 2028-02 NCT07481357

    DA-3501

    Histologically or cytologically documented advanced CLDN18.2+ GC/GEJ adenocarcinoma or advanced CLDN18.2+ PDAC

    Gastric (Stomach) Cancer, GastroEsophageal Cancer, Pancreatic Ductal Adenocarcinoma (mPDAC)

76. Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors

    Active, not recruiting Phase 1 Baili-Bio / SystImmune Started 2025Primary completion 2027-02 NCT07021066

    BL-M05D1

    …ented locally advanced or metastatic solid tumor(s) that are known to potentially express CLDN18.2, as defined below, that have recurred or progressed on at least 1 line of prior systemic …

    Gastric Adenocarcinoma, Advanced Pancreatic Ductal Adenocarcinoma, Esophageal Adenocarcinoma, Biliary Tract Cancer

77. A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer

    Active, not recruiting Phase 1 Astellas Started 2025Primary completion 2026-12 NCT06396091

    zolbetuximab FDA EUmFOLFIRINOX

    Participant's tumor is CLDN18.2 positive, defined as ≥ 75% of tumor cells demonstrating moderate to strong membranous CLD…

    Metastatic Pancreatic Adenocarcinoma

78. Postoperative Adjuvant Therapy for CT041 Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma Patients

    Not yet recruiting Phase 1 Peking University Started 2025Primary completion 2027-06 NCT06857786

    satricabtagene autoleucel

    Must have CLDN18.2-positive tumor expression as determined by immunohistochemistry (IHC), defined as CLDN18.…

    Gastroesophageal Junction Adenocarcinoma, Gastric Adenocarcinoma

79. Treating Claudin18.2-positive Advanced Solid Tumors with XKDCT225(Targeting Claudin18.2-CAR-T)

    Recruiting Phase 1 Shenzhen Celconta Life Science Started 2025Primary completion 2028-01 NCT06782425

    XKDCT225

    …c junction adenocarcinoma, esophageal adenocarcinoma) with moderate to high expression of Claudin18.2 (expression intensity ≥ 2+ and tumor cell positive rate ≥ 50 %), and whose condition cann…

    Claudin18.2 Positive Advanced Solid Tumors

80. A Phase I Study OfLNF2007 Monotherapy in Patients with Advanced Solid Tumors

    Not yet recruiting Phase 1 Shandong New Time Pharmaceutical Started 2025Primary completion 2026-12 NCT06752447

    LNF2007

    Tumor tissue samples were confirmed to be Claudin18.2 positive by immunohistochemical (IHC) detection, and positive was defined as ≥1+ by IHC d…

    Advanced Solid Tumors (Phase 1)

81. A Clinical Trial of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients

    Recruiting Phase 1 Shanghai Institute Of Biological Products Started 2025Primary completion 2028-05 NCT06985368

    SIBP-A18

    Queue 1: CLDN18.2 positive late stage gastric cancer/gastroesophageal junction cancer (GC/GEJC) confirmed b…

    Solid Tumor Malignancy

82. Exploratory Clinical Study of Claudin18.2-Targeted CAR-DC and CAR-T Therapy in Advanced Colorectal Cancer

    Recruiting Phase 1 Second Affiliated Hospital, Zhejiang University, School of Medicine Started 2025Primary completion 2026-04 NCT06946615

    Claudin18.2-targeted CAR-T CellsClaudin18.2-targeted CAR-DCs

    Claudin18.2 expression must be confirmed as positive in tumor tissue by immunohistochemistry (IHC).

    Colorectal Neoplasia

83. Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors

    Recruiting Phase 1 Sichuan University Started 2024Primary completion 2026-10 NCT06084286

    Dual-targeting CLDN18.2 and PD-L1 CAR-T cells

    Must have CLDN18.2-positive tumor expression ≥10% as determined by the CLDN18.2 IHC assay;

    Advanced Solid Tumor

84. NKG2D/CLDN18.21 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumor

    Recruiting Phase 1 Peking University Started 2024Primary completion 2027-06 NCT06134960

    KD-496

    Immunohistochemistry confirmed that NKG2DL/CLDN18.2 was positive (the sum of NKG2DL and CLDN18.2 positive scores ≥5 according to the principl…

    Gastric Cancer, Pancreatic Cancer, Solid Tumor

85. SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor

    Recruiting Phase 1 Jiangsu Hengrui Started 2024Primary completion 2027-12 NCT06350006

    SHR-A1904adebrelimabCAPOX

    6. positive CLDN18.2 expression in tumor tissue;

    CLDN18.2-positive Advanced Solid Tumor

86. SG1906 for CLDN18.2-Positive Solid Tumors

    Recruiting Phase 1 Hangzhou Sumgen Biotech Started 2023Primary completion 2027-02 NCT05857332

    SG1906

    Patients with CLDN18.2-positive histologically or cytologically confirmed locally advanced unresectable or metas…

    Locally Advanced Unresectable or Metastatic Solid Tumors

87. Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma

    Active, not recruiting Phase 1 Legend Biotech USA Started 2023Primary completion 2027-12 NCT05539430

    LB1908

    Presence of CLDN18.2 positive tumors with staining intensity of ≥ 1+ in ≥ 50% of tumor cells by immunohistoche…

    Gastric Cancer, Gastroesophageal-junction Cancer, Esophageal Cancer, Pancreatic Cancer

88. A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors

    Recruiting Phase 1 Antengene Biologics Started 2023Primary completion 2027-12 NCT05718895

    ATG-022

    Dose Expansion Phase: Claudin 18.2 positive solid tumors.

    Advanced/Metastatic Solid Tumors

89. A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer

    Recruiting Phase 1 CARsgen Therapeutics Started 2023Primary completion 2026-12 NCT05911217

    satricabtagene autoleucel

    Immunohistochemistry (IHC) staining of subject's tumor tissue sample is CLDN18.2-positive;

    Pancreatic Cancer

90. A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

    Recruiting Phase 1 Innovent Biologics Started 2022Primary completion 2027-06 NCT05458219

    IBI343FOLFIRINOXmFOLFIRINOXmFOLFOX

    …dies, ADCs, CAR-T, etc.), tumor samples should be obtained post anti-CLDN18.2 therapy for CLDN18.2 expression evaluation.

    Locally Advanced Unresectable or Metastatic Solid Tumors

91. A Study of SKB315 in Patients With Advanced Solid Tumors

    Recruiting Phase 1 Kelun-Biotech Started 2022Primary completion 2026-06 NCT05367635

    SKB315 for injectioncapecitabine

    …r tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 expression as determined by IHC

    Advanced Solid Tumors

92. Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

    Recruiting Phase 1 I-Mab Biopharma US Started 2021Primary completion 2026-12 NCT04900818

    TJ033721 (givastomig)nivolumabTJ033721 (givastomig), chemotherapydurvalumab

    Must have CLDN18.2-positive tumor expression

    Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer

93. GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR-T Cells Against Cancers

    Recruiting Phase 1 Second Affiliated Hospital of Guangzhou Medical University Started 2017Primary completion 2026-08 NCT03198052

    CAR-T cells targeting GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA,

    Patients with advanced cancer that expresses GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR protein

    Status may be outdated, last updated 2024-06-25Lung Cancer, Cancer, Immunotherapy, CAR-T Cell

94. Exploratory Clinical Study of Claudin18.2-Targeted Activated DC and CAR-T Therapy in Advanced Pancreatic Cancer.

    Recruiting Early Phase 1 Hainan Cancer Hospital Started 2026Primary completion 2028-02 NCT07416240

    Claudin18.2 Targeted Activated Dendritic CellsClaudin18.2 Targeted CAR-T Cells

    Tumor tissue positive for Claudin 18.2 by immunohistochemical detection (expression intensity ≥ 2+

    Advanced Pancreatic Cancer

95. Clinical Study of CBG131 CAR-T Cell Injection for the Treatment of CLDN18.2-Positive Advanced Gastric and Pancreatic Cancer

    Not yet recruiting Early Phase 1 First Affiliated Hospital of Wenzhou Medical University Started 2026Primary completion 2027-03 NCT07394205

    CBG131 CAR-T Cell Infusion

    CLDN18.2 positivity in archival or fresh tumor tissue by immunohistochemistry (IHC): ≥ 40% of tumo…

    Advanced Gastric and Pancreatic Cancer

96. A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled IR199 in Patients With Gastric Cancer and Pancreatic Cancer

    Recruiting Early Phase 1 Huashan Hospital Started 2026Primary completion 2027-04 NCT07707531

    [68Ga]/ [131I]-IR199

    Histologically or cytologically confirmed gastric cancer or pancreatic cancer with Claudin 18.2 expression.

    Gastric Cancer, Pancreatic Cancer

97. Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors

    Not yet recruiting Early Phase 1 Peking University Shenzhen Hospital Started 2026Primary completion 2028-04 NCT07504445

    CAR-DC treatment

    Diagnosed as EphA2or Claudin18.2, TROP2, HER2, GCC, GPC-3, CEA positive advanced solid tumors, such as lung cancer, liver …

    Advanced Solid Tumors

98. An Early Clinical Study to Evaluate the Safety and Efficacy of CLDN18.2 CAR T Cell Injection in Subjects With CLDN18.2-Positive Advanced Malignant Solid Tumors

    Recruiting Early Phase 1 Celest Therapeutics Started 2025Primary completion 2027-12 NCT07680257

    SUV2208A cell injectionSUV2208A

    … histology confirmed advanced malignant solid tumors, with moderate to high expression of CLDN18.2;

    CLDN18.2 Positive Solid Tumors

99. Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Advanced Solid Cancers

    Recruiting Early Phase 1 Hainan Cancer Hospital Started 2025Primary completion 2027-12 NCT07475182

    Targeted Activated Dendritic CellsTargeted CAR-T Cells

    Tumor tissue positive for Claudin 18.2, GCC, TROP2, or PSMA targets by immunohistochemistry (IHC) (expression intensity ≥ 2+

    Advanced Solid Cancers

100. A IIT Study of 177Lu-DOTA-SNA040

     Recruiting Early Phase 1 SmartNuclide Biopharma Started 2025Primary completion 2025-11 NCT07595237

     177Lu-DOTA-SNA040

     At least one lesion must be immunohistochemistry positive for Claudin18.2 (≥ 20% of tumor cells have Claudin18.2 immunohistochemistry membrane staining intensity ≥…

     Advanced Solid Tumors (Such as Gastric Cancer), Advanced Solid Tumors (Such as Adenocarcinoma at the Gastroesophageal Junction), Advanced Solid Tumors (Such as Pancreatic Cancer), Advanced Solid Tumors (Such as Cholangiocarcinoma)

101. Preliminary Trial of SNA014 for Pancreatic Cancer

     Recruiting Early Phase 1 SmartNuclide Biopharma Started 2025Primary completion 2026-07 NCT07597772

     68Ga-NODAGA-SNA006

     A Clinical Study on the Use of ⁶⁸Ga-labelled Claudin 18.2 as a Contrast Agent in Combination With PET/CT for the Imaging of Pancreatic Cancer

     Pancreatic Cancer

102. CAR-T for Claudin18.2 Positive Solid Tumors

     Not yet recruiting Early Phase 1 Chengdu Ucello Biotechnology Started 2025Primary completion 2035-12 NCT07266311

     claudin18.2 CAR-T

     Tumor tissue testing meets the requirement: Positive for Claudin 18.2 (CLDN18.2) by immunohistochemistry (IHC) staining.

     Claudin18.2 Positive Advanced Solid Tumors

103. Phase IIT Trial of SNA014

     Not yet recruiting Early Phase 1 SmartNuclide Biopharma Started 2024Primary completion 2025-10 NCT06646783

     [68Ga]Ga-NODAGA-SNA014

     Pathological test results and Claudin18.2 immunohistochemistry results within the past year (if available).

     Status may be outdated, last updated 2024-10-17Adenocarcinoma of the Stomach, Adenocarcinoma of GE Junction, Pancreatic Cancer Stage

104. Laparoscopic Staging for Stage III Gastric Cancer

     Enrolling by invitation No phase Tianjin Medical University Cancer Institute and Hospital Started 2025Primary completion 2026-12 NCT07533825

     Definitive pathological markers: Documented status of HER2, MMR, CPS (PD-L1) score, and Claudin 18.2.

     Gastric Cancer (GC), Gastric Adenocarcinoma

105. CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors

     Recruiting No phase Peking University Cancer Hospital & Institute Started 2022Primary completion 2026-12 NCT05436093

     18F-FDG

     CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors

     Solid Tumor

106. Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T

     Recruiting No phase Shenzhen University General Hospital Started 2022Primary completion 2025-10 NCT05620732

     Claudin18.2 CAR-T cells

     Immunohistochemical staining confirmed that Claudin 18.2 was moderately and highly expressed in tumor tissues;

     Status may be outdated, last updated 2022-11-22Advanced Pancreatic Carcinoma, Advanced Gastric Carcinoma

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