Astellas

Biomarkers

• Claudin 18.2 expression10
• KRAS G12D3
• KRAS G12C1
• FLT3 mutation (ITD/TKD)1
• ALK fusion1

Drugs in these trials

Targeted, immune and antibody-drug-conjugate therapies named in the company's active biomarker-selected trials (including other companies' drugs used in combination).

zolbetuximab 7pembrolizumab 4setidegrasib 3gilteritinib 2venetoclax 1nivolumab 1panitumumab 1cetuximab 1

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months, according to the sponsor.

• 2026-10 A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer Phase 2 · Claudin 18.2 expression
• 2026-12 XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies. Phase 1/2 · Claudin 18.2 expression
• 2027-06 A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer Phase 2 · Claudin 18.2 expression

Trials

16 of 34 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. A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

   Recruiting Phase 3 Astellas Started 2026Primary completion 2029-08 NCT07409272

   setidegrasiboxaliplatinleucovorinirinotecanfluorouracilliposomal irinotecan

   …G12D mutation based on local or central testing (confirmation of a participant's positive KRAS G12D mutation result must be available prior to randomization).

   KRAS G12DPancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma

3. A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation

   Recruiting Phase 3 Astellas Started 2026Primary completion 2030-06 NCT07566052

   setidegrasibdocetaxel

   The participant's positive KRAS G12D mutation result (either in tumor tissue or plasma ctDNA) must be available prior to rando…

   KRAS G12DNon-small Cell Lung Cancer (NSCLC)

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.

   Claudin 18.2 expressionGastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma

5. 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

6. 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

7. 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

8. 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.

   Claudin 18.2 expressionGastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma, Pancreatic Adenocarcinoma

9. A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia

   Active, not recruiting Phase 1/2 Astellas Started 2023Primary completion 2028-07 NCT05520567

   gilteritinib FDA EUvenetoclaxazacitidine

   Participant is positive for FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication \[ITD\] and/or tyrosine kinase domain \[TKD\] \[D835/I836\] …

   FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia (AML), FLT3-mutated Acute Myeloid Leukemia

10. 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.

    Claudin 18.2 expressionPancreatic Adenocarcinoma Metastatic, Lung Cancer (NSCLC), Ovarian Cancer, Colorectal Cancer Metastatic

11. 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

12. 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

13. A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors

    Recruiting Phase 1 Astellas Started 2025Primary completion 2028-11 NCT07094204

    ASP5834panitumumab FDA

    …alignancy with a documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification (copy number \>/= 4) determined by loc…

    KRAS G12CKRAS G12DSolid Tumor, Non-Small-Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer

14. A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)

    Recruiting Phase 1 Astellas Started 2025Primary completion 2029-12 NCT07140016

    gilteritinib

    …tastatic non-small cell lung cancer (NSCLC) with a documented anaplastic lymphoma kinase (ALK) rearrangement and is not amenable to curative intent treatment.

    ALK fusionNon-small Cell Lung Cancer (NSCLC), Anaplastic Lymphoma Kinase (ALK) Positive

15. 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

16. A Study of ASP3082 in Adults With Advanced Solid Tumors

    Recruiting Phase 1 Astellas Started 2022Primary completion 2028-12 NCT05382559

    setidegrasibcetuximableucovorinoxaliplatinfluorouracilirinotecannab-paclitaxelgemcitabinedocetaxelpembrolizumabcisplatincarboplatin

    … lung cancer (NSCLC) (Note: for Cohort H only, the tumor must be non-squamous NSCLC) with KRAS G12D mutation and

    KRAS G12DSolid Tumor

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