Skip to main content

zolbetuximab

Generic: zolbetuximab·Brand: Vyloy

zolbetuximab: 7 clinical trials tracked.

zolbetuximab evidence translation

What we can confirm

7 tracked trials

No verified listed company relationship

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about zolbetuximab, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence5 indications · 1 study sponsors
Clinical Trial Registry Records (7)

AACR Adaptive Biomarker-Driven Organ Preservation Trial In Gastroesophageal Adenocarcinomas (AACR-ADOPT-GEA)

NCT07290985Registry updated 2026-10-05·Phase 2
Recruiting

Primary endpoint: Pathological Complete Response (pathCR) Rate (Stage I).

Interventionalopen242 targetStarted 2026-07Completion 2028-124 sites · Canada, United StatesAmerican Association for Cancer Research

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

NCT07431281Registry updated 2026-09-09·Phase 3·AZN
Recruiting

Primary endpoint: Progression Free Survival (PFS) (Cohort 1 and Cohort 2)

InterventionalRandomizedsingle2,130 targetStarted 2026-02Completion 2031-1050 sites · United StatesAstraZeneca

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive

NCT06901531Registry updated 2026-07-31·Phase 3
Recruiting

Primary endpoint: Overall Survival (OS)

InterventionalRandomizeddouble500 targetStarted 2025-05Completion 2027-0350 sites · Australia, Belgium, Brazil, United StatesAstellas Pharma Global Development, Inc.

A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

NCT03816163Registry updated 2026-07-14·Phase 2
Active, not recruiting

Primary endpoint: Dose Limiting Toxicities (DLT) - (safety lead in)

InterventionalRandomizedopen393 enrolledStarted 2019-03Completion 2026-0850 sites · Australia, Brazil, China, United StatesAstellas Pharma Global Development, Inc.

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy 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

NCT03653507Registry updated 2026-07-16·Phase 3
Active, not recruiting

Primary endpoint: Progression Free Survival (PFS)

InterventionalRandomizeddouble507 enrolledStarted 2018-11Completion 2026-0950 sites · Argentina, Canada, China, United StatesAstellas Pharma Global Development, Inc.

A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy and in Combination With Chemotherapy and/or Immunotherapy in Subjects With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma Whose Are Claudin (CLDN) 18.2 Positive

NCT03505320Registry updated 2026-06-18·Phase 2
Active, not recruiting

Primary endpoint: Objective Response Rate (ORR) of zolbetuximab as a single agent by central review (Cohort 1)

Interventionaldouble143 targetStarted 2018-06Completion 2027-1121 sites · France, Italy, Japan, South Korea…Astellas Pharma Global Development, Inc.

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 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

NCT03504397Registry updated 2026-05-04·Phase 3
Active, not recruiting

Primary endpoint: Progression Free Survival (PFS)

InterventionalRandomizeddouble565 targetStarted 2018-06Completion 2026-0950 sites · United StatesAstellas Pharma Global Development, Inc.