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

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT07829757
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zolbetuximab — DRUG
    Participants will receive an IV infusion of zolbetuximab once every 2 or 3 weeks.
  • Oxaliplatin — DRUG
    Participants receiving mFOLFOX6 or CAPOX regimen of chemotherapy will receive an IV infusion of oxaliplatin once every 2 or 3 weeks.
  • Folinic Acid — DRUG
    Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion of folinic acid once every 2 weeks.
  • 5-fluorouracil — DRUG
    Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion or IV bolus of 5-FU once every 2 weeks.
  • Capecitabine — DRUG
    Participants receiving CAPOX regimen of chemotherapy will receive an oral capecitabine tablet twice daily on Days 1 through 14 and Days 22 through 35 of each cycle.

Study Details

There is an unmet medical need to treat people with advanced cancer in the stomach and the junction area where the stomach joins the food pipe. These conditions are known as advanced or stomach (gastric) cancer and advanced gastroesophageal junction cancer (GEJ cancer for short). Zolbetuximab is an approved treatment in many countries for people with advanced stomach cancer and advanced GEJ cancer. Some people with these cancers have a protein called Claudin 18.2 on their tumor but they do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative). Zolbetuximab works by attaching to the Claudin 18.2 protein on their tumor. This switches on the body's immune system to attack the tumor. In India, the standard chemotherapies used are mFOLFOX6 or CAPOX. The main aim of the study is to check the safety of zolbetuximab when given with mFOLFOX6 or CAPOX chemotherapies in people in India with advanced stomach or GEJ cancer. It will also check how well zolbetuximab controls stomach cancer and GEJ cancer when given with mFOLFOX6 or CAPOX.

Key Dates

First listed
Sep 21, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zolbetuximab Plus mFOLFOX6 or CAPOX
    Participants will receive an intravenous (IV) infusion of zolbetuximab at a loading dose of 800 mg/m\^2 on Cycle 1 Day 1 (C1D1) followed by 400 mg/m\^2 every 2 weeks if combined with mFOLFOX6 or 600 mg/m\^2 every 3 weeks if combined with CAPOX. Participants will receive chemotherapy over 4 or more cycles of either up to 12 mFOLFOX6 treatments (oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2, 5-fluorouracil \[FU\] bolus: 400 mg/m\^2, 5-FU infusion: 2400 mg/m\^2) once every 2 weeks, or up to 8 CAPOX treatments (oxaliplatin: 130 mg/m\^2 once every 3 weeks, capecitabine: 1000 mg/m\^2 twice daily on Days 1 through 14 and 22 through 35 of each cycle). Each cycle is approximately 42 days. Treatment will continue at the investigator's discretion until the participant meets study intervention discontinuation criteria.

Primary Outcome Measure

Number of participants with adverse events (AEs) [ Time Frame: Up to 32 months ]

Central Contacts

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