Recruiting

JNJ-95437446 for Advanced Solid Tumors

What is being tested

JNJ-95437446

Drug

Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: July 2025

See protocol details

Summary

Principal SponsorJanssen Research & Development, LLC

Study ContactStudy Contact

Last updated: January 17, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 15, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on evaluating a new medication, JNJ-95437446, for people with advanced-stage solid tumors. The main goal is to find the best dose of this new treatment by determining the recommended phase 2 doses. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas, and they can occur in various parts of the body. This study is important because it seeks to find a safer and more effective treatment option for patients whose cancer has progressed to an advanced stage, where current treatments might be less effective. In the study, participants will receive the medication JNJ-95437446, and researchers will monitor them to determine the most suitable dosage. This process helps ensure that future patients receive a dose that balances effectiveness with safety. The study is conducted in two parts: the first part determines the appropriate doses, and the second part evaluates the safety of these doses in more detail. While the study does not list specific risks or benefits, clinical trials typically involve careful monitoring to minimize risks and ensure participants' safety throughout the process.

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

NCT07107230

Principal SponsorJanssen Research & Development, LLC

Study ContactStudy Contact

Last updated: January 17, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

380 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

6 inclusion criteria required to participate

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

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 measurable or evaluable disease:

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

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5 exclusion criteria prevent from participating

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

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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Recruiting

Florida Cancer Specialists

Sarasota, United StatesSee the location

Recruiting

NEXT Oncology

Fairfax, United States

Recruiting

Severance Hospital Yonsei University Health System

Seoul, South Korea

Recruiting

Samsung Medical Center

Seoul, South Korea

Recruiting

6 Study Centers