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NCT07107230PHASE1Recruiting

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

Janssen Research & Development, LLC

Start Date

7/15/2025

Completion Date

4/24/2028

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants must have been previously diagnosed with histologically confirmed unresectable, locally advanced, or metastatic non-small cell lung cancer, colorectal carcinoma, or head and neck squamous cell carcinoma * Participants with non-small cell lung cancer (NSCLC) adenocarcinoma and colorectal cancer (CRC) must have local molecular testing to determine epidermal growth factor receptor (EGFR) mutational status for NSCLC and Kirsten rat sarcoma/neuroblastoma ras viral oncogene/v-raf murine sarcoma oncogene B1 (KRAS/NRAS/BRAF) mutation status for CRC * Have measurable or evaluable disease: * Part 1: Either measurable or evaluable disease; Part 2: At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version (v) 1.1 * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 at screening * Participants must have appropriate hematologic, renal, and hepatic function within the required limits Exclusion Criteria: * Any prior medical history of ILD/pneumonitis, including pneumonitis from anti-PD-1/ PD-L1 antibody or radiation that required systemic steroids * Toxicity from prior anticancer therapy that has not resolved to Grade \<=1 * Evidence of clinically significant active viral, bacterial, or fungal infection within 7 days before the first dose of study treatment requiring systemic or non-topical treatment * History of clinically significant cardiovascular disease within 6 months prior to signing informed consent * Participants with prior or concurrent second malignancy cannot be enrolled if prior/concurrent malignancy's natural history of treatment is likely to interfere with any safety or efficacy study endpoints

Interventions

DRUG

JNJ-95437446

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Conditions

Colorectal Neoplasms

Locations

Florida Cancer Specialists

Sarasota, Florida 34232

United States

Columbia University Medical Center Herbert Irving Pavilion

New York, New York 10032

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

NEXT Oncology

Fairfax, Virginia 22031

United States

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Hosp Univ Vall D Hebron

Barcelona, 8035

Spain

Hosp Univ Fund Jimenez Diaz

Madrid, 28040

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp Univ Hm Sanchinarro

Madrid, 28050

Spain