A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers
Condition(s) studied
Investigational drug(s) / intervention(s)
JNJ-89402638: JNJ-89402638 will be administered.
Bevacizumab: Bevacizumab or biosimilar will be administered.
FOLFOX: Chemotherapy agent FOLFOX will be administered.
FOLFIRI: Chemotherapy agent FOLFIRI will be administered.
Study summary
The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) 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
Primary outcome measure(s)
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity — From Baseline up to approximately 24 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus. - Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) — From Baseline up to 28 days
The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities.
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | Recruiting |
| University of Colorado Denver Anschultz Medical Campus | Aurora | Colorado | Recruiting |
| Florida Cancer Specialists | Sarasota | Florida | Recruiting |
| Community Health Network | Indianapolis | Indiana | Recruiting |
| Start Midwest | Grand Rapids | Michigan | Recruiting |
| Swedish Cancer Institute | Seattle | Washington | Recruiting |
| Severance Hospital Yonsei University Health System | Seoul | South Korea | Recruiting |
| Asan Medical Center | Seoul | South Korea | Recruiting |
| Hosp Univ Vall D Hebron | Barcelona | Spain | Recruiting |
| Hosp Univ Fund Jimenez Diaz | Madrid | Spain | Recruiting |
| Hosp. Univ. 12 de Octubre | Madrid | Spain | Recruiting |
| Hosp Univ Hm Sanchinarro | Madrid | Spain | Recruiting |
On this site
📄 Avastin (bevacizumab) drug profile →More Janssen Research & Development, LLC trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06663319 on ClinicalTrials.gov ↗ ← All trials in the USA