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

NCT07107230 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 95437446LUC10012025-521535-36-00
• Study Type: interventional
• Target: 380
• Locations: 3 countries
• Sites: 9

Brief 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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events (AEs) by Severity

  An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

  Up to 2 years and 4 months

• Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

  The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation.

  Up to 21 days

Secondary Outcomes (7)

• Objective Response Rate

  Up to 2 years and 4 months

• Duration of Response (DOR)

  Up to 2 years and 4 months

• Progression Free Survival (PFS)

  Up to 2 years and 4 months

• Maximum Plasma Concentration (Cmax) for JNJ-95437446

  Up to 2 years and 4 months

• Time to Reach Cmax (Tmax) for JNJ-95437446

  Up to 2 years and 4 months

Study Arms (1)

JNJ-95437446

EXPERIMENTAL

Participants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2 doses (RP2Ds) has been developed. Participants in Part 2 will receive JNJ-95437446 at the RP2Ds developed in Part 1.

Drug: JNJ-95437446

Interventions

JNJ-95437446 DRUG

JNJ-95437446 will be administered.

JNJ-95437446

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (9)

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

NEXT Oncology

Fairfax, Virginia, 22031, United States

RECRUITING

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Hosp Univ Vall D Hebron

Barcelona, 8035, Spain

RECRUITING

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hosp Univ Hm Sanchinarro

Madrid, 28050, Spain

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 6, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): November 18, 2027
• Study Completion (Estimated): April 24, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

KR (2); ES (4); US (3)