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zolbetuximab

Generic: zolbetuximab·Brand: Vyloy

zolbetuximab: 7 clinical trials tracked.

zolbetuximab evidence translation

What we can confirm

7 tracked trials

No verified listed developer

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 evidence4 indications · 1 study sponsors
Clinical Trials (7)

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

NCT07290985·Phase 2
Recruiting

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

Interventionalopen242 targetStarted 2026-07Completion 2028-123 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)

NCT07431281·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

NCT06901531·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

NCT03816163·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

NCT03653507·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

NCT03505320·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

NCT03504397·Phase 3
Active, not recruiting

Primary endpoint: Progression Free Survival (PFS)

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