Spotlight : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractGastro-oesophageal junction ,Stomach

Trial Overview Read MoreRead more

This phase III trial is comparing treatment with an intravenous drug (Zolbetuximab) and chemotherapy (mFOLFOX6), versus chemotherapy alone, in patients with CLDN, HER2- advanced or metastatic gastric or gastroesophageal junction cancer.
 

This trial is treating patients with gastric or gastroesophageal junction cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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

Commercial Sponsor

Astellas Pharma Inc.

Summary

Patients in this trial will be randomised into one of two treatment arms. In Experimental Arm A, patients will receive a loading dose of zolbetuximab at Cycle 1 Day 1 followed by a lower dose in subsequent cycles every 3 weeks. Additionally, participants will receive 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 cycles (each cycle has 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. In Placebo Arm B, patients will receive a placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 cycles (each cycle has 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. All patients in this trial may continue to receive fluorouracil (5-FU) and leucovorin at the investigator's discretion until the subject meets study treatment discontinuation criteria.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
GI Research Study Coordinator
gi.oncresearch@monashhealth.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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