IRB #

STUDY00018340

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

Principal Investigator

Adel Kardosh

Study Purpose

The purpose of this study is to see if an experimental study drug, called IMAB362, is both safe and effective as a treatment in combination with the chemotherapy regimen mFOLFOX6 for gastric and gastroesophageal junction (GEJ) cancer. mFOLFOX6 is a combination of medications currently approved for the treatment of gastric and GEJ cancer. The study drug targets a protein present in gastric cancer to help treat gastric cancer. The study drug is not FDA-approved.

Medical Condition(s)

gastric and GEJ cancer

Eligibility Criteria

-18 years and older male or female
-Histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma
-Radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to the first dose of study treatment.

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive either the study drug or placebo every 3 weeks for a total of 8 treatments during the first 4 cycles of this study. In this study, each cycle lasts 42 days. Participants will also receive mFOLFOX6 every 2 weeks (for a total of 12 treatments) during the first 4 cycles of this study.
After the first 4 cycles on the study, participants will continue to receive the study drug or Placebo every 3 weeks. In addition, the investigator will determine if it is in the participants best interest to continue to receive mFOLFOX6 will be discontinued after 4 cycles (12 treatments) as it is only recommended for a total of 4 cycles (12 treatments). Participants will receive the study drug as long as their cancer does not get worse and they do not have bad side effects.

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503 494-1080

Sponsor

Astellas Pharma Global Development, Inc.

Recruitment End

11/30/2030

Compensation Provided

No


Go Back