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A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06663319•Janssen Research & Development, LLC

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For Part 1 (dose escalation), Part 2 (Arm A \[JNJ-89402638 monotherapy\]): Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm B (JNJ-89402638 + bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of CRC progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm C (JNJ-89402638 + FOLFOX/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting. Must not have received oxaliplatin previously for metastatic disease; For Part 2 Arm D (JNJ-89402638 + FOLFIRI/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting. Must not have received irinotecan previously for metastatic disease; For Part 2 Arm E (JNJ-89402638 monotherapy in mGAC): Have histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting
•Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1
•1. Part 1: Must have either measurable or evaluable disease
•2. Part 2: Must have at least 1 measurable lesion
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
•Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (\>=) 30 milliliter per minute (mL/min) based on modification of diet in renal disease (MDRD) 4-variable formula

Exclusion Criteria

•Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression
•Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (\<=)1 (except alopecia, vitiligo, Grade \<= 2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement). For Part 2 Arm C: Grade 2 or higher peripheral neuropathy is considered exclusionary
•Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
•Received glucocorticoids (doses \>10 mg/day prednisone or equivalent) within 7 days prior to the first dose of study drug
•Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment

Locations (9)

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

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

Key Dates

Start Date

October 15, 2024

Primary Completion Date

February 25, 2028

Completion Date

July 19, 2028

Last Updated

March 13, 2026

Enrollment

220

ESTIMATED participants

Conditions

Colorectal NeoplasmsGastrointestinal Neoplasms

Interventions

JNJ-89402638

DRUG

Bevacizumab

DRUG

FOLFOX

DRUG

FOLFIRI

DRUG

Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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