Actively Recruiting
A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
220
Participants Needed
11
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find the recommended Phase 2 dose(s) (RP2Ds) of JNJ-89402638 and to assess its safety in people with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC). The study also evaluates the safety and tolerability of JNJ-89402638 when combined with bevacizumab or its biosimilar, with or without chemotherapy, in participants with mCRC. It is a Phase 1 trial sponsored by Janssen Research & Development, LLC focusing on these gastrointestinal cancers. Participants with unresectable metastatic colorectal adenocarcinoma will first receive escalating doses of JNJ-89402638 to identify the RP2D for monotherapy. After this dose is determined, participants with mCRC will receive JNJ-89402638 alone or combined with bevacizumab or biosimilar, with or without chemotherapy agents FOLFOX or FOLFIRI. People with metastatic gastric adenocarcinoma will receive JNJ-89402638 at the RP2D established in the first part of the study. During the study, participants will be monitored for adverse events and dose-limiting toxicities up to 24 months. Researchers will measure serum concentrations of JNJ-89402638, the presence of antibodies against the drug, and treatment responses including overall and complete responses, time to response, and duration of response. Safety and tolerability will be closely tracked, with participants undergoing regular evaluations throughout the study period, which may last up to two years.
CONDITIONS
Brief Title
A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with colorectal adenocarcinoma or gastric adenocarcinoma progressing after prior standard therapies
- For certain groups, must have microsatellite stable or proficient mismatch repair colorectal cancer
- Must have measurable or evaluable disease per RECIST version 1.1
- ECOG performance status of 0 or 1
- Kidney function (GFR) of 30 mL/min or higher based on MDRD formula
You will not qualify if you...
- Active or progressive brain metastases, leptomeningeal disease, or untreated spinal cord compression
- Unresolved significant toxicity from prior anticancer therapy (Grade >1), except some stable conditions
- Prior or concurrent second malignancy unless unlikely to interfere with study outcomes
- Use of glucocorticoids over 10 mg/day prednisone equivalent within 7 days before study drug
- Receipt or planned receipt of live, attenuated vaccine within 4 weeks before or after study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months
Participants receive JNJ-89402638 alone or in combination with bevacizumab, FOLFOX, or FOLFIRI chemotherapy depending on their assigned group.
Regular visits for treatment and monitoring
Trial Site Locations
Total: 11 locations
1
University of Colorado Denver Anschultz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
3
Community Health Network
Indianapolis, Indiana, United States, 46256
Actively Recruiting
4
Start Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
5
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
6
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
7
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
8
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
9
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
10
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
11
Hosp Univ Hm Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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