Phase 1 Trial Evaluating JNJ-95437446 Treatment for Advanced Solid Tumors Including Colorectal, Lung, and Head and Neck Cancers

What this Trial Is About

Researchers are studying JNJ-95437446 in participants with advanced solid tumors, including colorectal cancer, non-small cell lung cancer, and head and neck cancer. The study aims to find the recommended phase 2 doses of JNJ-95437446 and to evaluate its safety in these participants. This is a phase 1 trial focused on treatment for advanced-stage solid tumors. Participants in Part 1 will receive JNJ-95437446 to determine at least two recommended phase 2 doses. In Part 2, participants will receive JNJ-95437446 at these established doses. The treatment involves administering the drug, and dose-limiting toxicities will be closely monitored in the initial 21 days. Participants will be involved in assessments of adverse events by severity for up to two years and four months. Researchers will measure responses such as objective response rate, duration of response, and progression-free survival. Additional evaluations include plasma concentrations of the drug and antibodies against it. Safety monitoring and follow-up will continue throughout the study duration until its completion in 2028.

A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors