RecruitingPhase 1NCT07107230

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

A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors


Sponsor

Janssen Research & Development, LLC

Enrollment

380 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called JNJ-95437446 in people with advanced non-small cell lung cancer, colorectal cancer, or head and neck squamous cell cancer that has stopped responding to standard treatments. This is an early-phase trial testing different doses to find what works safely. **You may be eligible if:** - You have been diagnosed with advanced or metastatic non-small cell lung cancer, colorectal cancer, or head and neck squamous cell carcinoma - Your cancer has progressed after prior treatment - Your cancer has been tested for specific genetic mutations (EGFR for lung cancer; KRAS/NRAS/BRAF for colorectal cancer) - Your overall health is good (ECOG 0–1) - You have measurable or evaluable disease on imaging **You may NOT be eligible if:** - You have a different type of cancer not listed above - You have not had prior treatment - You have serious organ problems or other active cancers - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-95437446

JNJ-95437446 will be administered.


Locations(9)

Florida Cancer Specialists

Sarasota, Florida, United States

Tennessee Oncology

Nashville, Tennessee, United States

NEXT Oncology

Fairfax, Virginia, United States

Severance Hospital Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp Univ Hm Sanchinarro

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT07107230


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