RecruitingPhase 1NCT06663319

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies


Sponsor

Janssen Research & Development, LLC

Enrollment

220 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) of JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called JNJ-89402638, alone or in combination with other cancer therapies, in people with advanced colorectal cancer (cancer of the colon or rectum) or gastric cancer (stomach or stomach-esophagus junction cancer) that has spread and progressed on prior treatments. **You may be eligible if...** - You are 18 or older - You have colorectal cancer that has spread and progressed after at least 1-2 prior lines of standard treatment (the specific number depends on which study arm you qualify for) - OR you have gastric or stomach-junction cancer that has progressed after at least 1 prior line of treatment - You have at least one measurable tumor on scans - Your general health and organ function are adequate **You may NOT be eligible if...** - Your cancer has not spread to distant sites or is eligible for surgery - You have certain genetic profiles that direct you to other treatments - You have serious heart, liver, kidney, or other health conditions that make experimental treatment unsafe - You have active brain metastases - You have previously received this specific drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-89402638

JNJ-89402638 will be administered.

DRUGBevacizumab

Bevacizumab or biosimilar will be administered.

DRUGFOLFOX

Chemotherapy agent FOLFOX will be administered.

DRUGFOLFIRI

Chemotherapy agent FOLFIRI will be administered.


Locations(10)

University of Colorado Denver Anschultz Medical Campus

Aurora, Colorado, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Community Health Network

Indianapolis, Indiana, United States

Start Midwest

Grand Rapids, Michigan, United States

Swedish Cancer Institute

Seattle, Washington, United States

Asan Medical Center

Seoul, South Korea

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp Univ Hm Sanchinarro

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT06663319


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