NCT06663319

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms
• Gastrointestinal Neoplasms

Interventions

Type	Name	Description
DRUG	JNJ-89402638	JNJ-89402638 will be administered.
DRUG	Bevacizumab	Bevacizumab or biosimilar will be administered.
DRUG	FOLFOX	Chemotherapy agent FOLFOX will be administered.
DRUG	FOLFIRI	Chemotherapy agent FOLFIRI will be administered.

Timeline

• Start date: 2024-10-15
• Primary completion: 2028-02-25
• Completion: 2028-07-19
• First posted: 2024-10-29
• Last updated: 2026-04-13

Locations

10 sites across 3 countries: United States, South Korea, Spain

Regulatory

• FDA-regulated drug study