Suspended

SpotlightZolbetuximab and mFOLFOX6 Treatment for CLDN18.2-Positive, HER2-Negative Gastric or GEJ Adenocarcinoma

Study Aim

This phase 3 study aims to evaluate the effectiveness of Zolbetuximab and mFOLFOX6 treatment in improving progression-free survival for individuals with CLDN18.2-positive, HER2-negative gastric or GEJ adenocarcinoma.

What is being tested

zolbetuximab

+ oxaliplatin

+ folinic acid

Drug

Who is being recruted

Adenocarcinoma+9

+ Carcinoma

+ Digestive System Diseases

Over 18 Years

+53 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: June 2018

See protocol details

Summary

Principal SponsorAstellas Pharma Global Development, Inc.

Last updated: February 14, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 21, 2018

Actual date on which the first participant was enrolled.

This study is a global, phase 3 clinical trial that aims to evaluate the effectiveness of a drug called Zolbetuximab (IMAB362) in combination with mFOLFOX6, compared to a placebo plus mFOLFOX6. The trial focuses on patients with Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma, a type of stomach or esophagus cancer. The goal of this research is to find a more effective first-line treatment for this specific type of cancer, potentially improving patient care and outcomes. In this trial, participants are randomly assigned to receive either Zolbetuximab plus mFOLFOX6 or a placebo plus mFOLFOX6. The primary outcome measured is Progression Free Survival (PFS), which is the time from the start of the treatment until the cancer worsens or the patient passes away from any cause. The worsening of cancer is determined by the development of new, or progression of existing metastases to the primary cancer. The study uses a method called Kaplan-Meier estimates to evaluate these outcomes.

Official TitleA 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

Principal SponsorAstellas Pharma Global Development, Inc.

Last updated: February 14, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

565 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialStomach DiseasesStomach Neoplasms

Criteria

24 inclusion criteria required to participate

Female subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies:

Not a woman of child-bearing potential (WOCBP) OR

WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs

Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.

Show More Criteria

29 exclusion criteria prevent from participating

Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.

Subject has significant gastric bleeding and/or untreated gastric ulcers that would exclude the subject from participation.

For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded.

Subject has received other investigational agents or devices within 28 days prior to randomization.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Participants received intravenous (IV) infusion (minimum 2-hour) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle1 day1(C1D1) followed by 600 mg/m\^2 every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received upto 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4/more cycles. mFOLFOX6 was administered on Days 1, 15 \& 29 of each cycle (5-FU:400mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85mg/m\^2 IV infusion over 2 hours) A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants continued to receive 5-FU \& Folinic acid on Days 1, 15 \& 29 of each cycle at the investigator discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.

Group II

Placebo

Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 220 locations

Suspended

University of Arizona

Phoenix, United StatesOpen University of Arizona in Google Maps

Suspended

The University of Arizona Medical Center

Tucson, United States

Suspended

CBCC Global Research, Inc. at Comprehensive Blood and Cancer

Bakersfield, United States

Suspended

City of Hope Nat'l Medical Center

Duarte, United States

Suspended220 Study Centers