marked.bio

anti-CLDN18.2 antibody · antibody

zolbetuximab

14 active trials across 2 of our biomarkers, targeting Claudin 18.2. 2 active approvals for a biomarker on marked.bio.

Also known as IMAB362, Vyloy.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
zolbetuximab with fluoropyrimidine + platinum chemotherapy
FDA, 2024
first line, locally advanced unresectable or metastatic HER2-negative, CLDN18.2-positive FDA approval 18/10/2024; companion test VENTANA CLDN18 (43-14A) RxDx Assay (positive = at least 75% of tumour cells with moderate-to-strong staining). Source
EU (EMA), 2024
first line, locally advanced unresectable or metastatic HER2-negative, Claudin 18.2-positive EU marketing authorisation 19/09/2024. Source
Vyloy 		Claudin 18.2 expression gastric/GEJ Approved 2024 Approved 2024

In the FDA approval summary

SPOTLIGHT and GLOW vs placebo + mFOLFOX6 (SPOTLIGHT) or CAPOX (GLOW), 565 (SPOTLIGHT); 507 (GLOW)
PFS 10.6 months (SPOTLIGHT); 8.2 months (GLOW) vs 8.7 months; 6.8 months, HR 0.75 (0.60-0.94) SPOTLIGHT; 0.69 (0.54-0.87) GLOWOS 18.2 months (SPOTLIGHT); 14.4 months (GLOW) vs 15.5 months; 12.2 months, HR 0.75 (0.60-0.94) SPOTLIGHT; 0.77 (0.62-0.97) GLOW

Trial details and side effects
Patients
CLDN18.2-positive HER2-negative gastric/GEJ adenocarcinoma, first line (NCT03504397)
Most common side effects
nausea, vomiting, decreased appetite (frequent with the first infusions)
Notes
FDA approval summary (2024); GLOW is NCT03653507. Nausea and vomiting are the main side effects, often during the first infusion.
Source
FDA approval summary

In the EU summary (EPAR)

SPOTLIGHT and GLOW vs placebo + mFOLFOX6 (SPOTLIGHT) or CAPOX (GLOW), 565 (SPOTLIGHT); 507 (GLOW)
PFS 11.0 months (SPOTLIGHT); 8.2 months (GLOW) vs 8.9 months; 6.8 months, HR 0.75 (0.60-0.94) SPOTLIGHT; 0.69 (0.54-0.87) GLOWOS 18.2 months (SPOTLIGHT); 14.3 months (GLOW) vs 15.6 months; 12.2 months, HR 0.75 (0.60-0.94) SPOTLIGHT; 0.77 (0.62-0.97) GLOW

Trial details and side effects
Patients
CLDN18.2-positive HER2-negative gastric/GEJ adenocarcinoma, first line (NCT03504397)
Most common side effects
nausea, vomiting, decreased appetite (frequent with the first infusions)
Notes
EU figures from the EPAR summary; trial details and side effects from the US approval.
Source
EU summary (EPAR)

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
Claudin 18.2 expression 14 18 Phase 4
MSI-H / dMMR 1 1 Phase 1/2

Sponsors

Industry sponsors leading active biomarker-selected trials of zolbetuximab.

  1. Astellas 7
  2. AstraZeneca 1

Trials

14 of 18 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…

    Claudin 18.2 expressionLocally 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. 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

    Claudin 18.2 expressionGastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer

  3. 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…

    Claudin 18.2 expressionLocally 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

  4. 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…

    Claudin 18.2 expressionLocally 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

  5. 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…

    Claudin 18.2 expressionLocally 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

  6. 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…

    Claudin 18.2 expressionAdvanced Biliary Tract Cancer, Metastatic Biliary Tract Carcinoma

  7. 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

    Claudin 18.2 expressionCLDN18.2-Positive Gastric Cancer, CLDN18.2-Positive Gastroesophageal Junction Adenocarcinoma

  8. 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…

    Claudin 18.2 expressionMSI-H / dMMRGC/GEJC

  9. 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);

    Claudin 18.2 expressionGastric Cancer, HER2 + Gastric Cancer, CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, PD-L1 Positive

  10. 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%)

    Claudin 18.2 expressionStomach Neoplasm, Gastric (Stomach) Cancer

  11. 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 …

    Claudin 18.2 expressionGastric Cancer Adenocarcinoma Metastatic, Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma

  12. 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…

    Claudin 18.2 expressionPancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma

  13. 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 …

    Claudin 18.2 expressionPharmacokinetics of Zolbetuximab, Gastric Cancer, Gastro-esophageal Junction (GEJ) Cancer, Pharmacokinetics of Oxaliplatin

  14. 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…

    Claudin 18.2 expressionMetastatic Pancreatic Adenocarcinoma