Phase 1 Study of JNJ-89402638 Alone or With Bevacizumab and Chemotherapy for Metastatic Colorectal and Gastric Cancers

What this Trial Is About

Researchers are evaluating JNJ-89402638 in participants with metastatic colorectal cancer mCRC and metastatic gastric cancer mGAC. The study aims to find the best dose and way to take this drug optimal route and assess its safety alone and combined with bevacizumab or biosimilar, with or without chemotherapy, in mCRC patients. This phase 1 trial focuses on treatment safety and determining the recommended phase 2 doses. The study has two main parts. In Part 1, participants with unresectable metastatic colorectal adenocarcinoma receive JNJ-89402638 alone with doses increased stepwise to find the recommended dose and optimal administration route. In Part 2, participants with mCRC receive JNJ-89402638 alone or combined with bevacizumab or biosimilar, and chemotherapy agents FOLFOX or FOLFIRI. Participants with metastatic gastric adenocarcinoma receive JNJ-89402638 alone at the recommended dose and route from Part 1. During the study, participants will be monitored for adverse events and dose-limiting toxicities up to about 24 months. Blood samples will be collected to measure drug levels and antibody presence, and tumor response will be evaluated using standard criteria. Safety and tolerability are closely observed, with ongoing assessments throughout treatment. Total participation may last up to two years, including safety follow-up and response evaluations.

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