Actively Recruiting
A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
220
Participants Needed
11
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed colorectal adenocarcinoma progressing after 2 or more prior standard therapies for metastatic/unresectable disease (Parts 1 and 2 Arm A and B)
- Histologically or cytologically confirmed microsatellite stable or proficient mismatch repair colorectal cancer progressing after 1 prior standard therapy, with no prior oxaliplatin or irinotecan for metastatic disease (Parts 2 Arms C and D)
- Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma progressing after 1 or more prior standard therapies for metastatic/unresectable disease (Part 2 Arm E)
- Evaluable or measurable disease per RECIST 1.1 criteria
- At least one measurable lesion for Part 2
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated or measured glomerular filtration rate (GFR) ≥ 30 mL/min by MDRD 4-variable formula
You will not qualify if you...
- Active new or progressive brain metastases, leptomeningeal disease, or untreated spinal cord compression
- Toxicity from prior anticancer therapy unresolved to Grade ≤ 1, except alopecia, vitiligo, Grade ≤ 2 peripheral neuropathy, or stable endocrinopathies on hormone replacement; Grade 2 or higher peripheral neuropathy excluded for Part 2 Arm C
- Prior or concurrent second malignancy unless unlikely to interfere with study safety or efficacy
- Use of glucocorticoids >10 mg/day prednisone or equivalent within 7 days before first study dose
- Receipt or planned receipt of live, attenuated vaccine within 4 weeks before first dose or after last dose of study treatment
AI-Screening
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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
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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