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A Study of JNJ-95437446 for Advanced Solid Tumors

This study is testing a drug called JNJ-95437446 in people with advanced solid tumors, specifically colorectal cancer. The main goals are to find the best dose of JNJ-95437446 and to understand its safety. You might be able to join if you are 18 or older, have advanced colorectal cancer, and have had specific molecular tests (biomarkers) for BRAF, EGFR, KRAS, or NRAS. The study aims to enroll about 380 participants. The current recruitment status is unclear, so it's best to check with the study team for more details.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 380 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events (side effects) for up to 2 years and 4 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07107230

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~380 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:JNJ-95437446

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Adverse Events (AEs) by Severity
Measured over Up to 2 years and 4 months
+1 more outcome measured

Conditions

Colorectal Neoplasms

Explore related trials

Colorectal CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaSolid Neoplasm

Where it's being run

10 sites across 6 states
Spain4
South Korea2
Florida1
New York1
Tennessee1
Virginia1

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of Participants with Adverse Events (AEs) by SeverityUp to 2 years and 4 months

    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.

  • Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)Up to 21 days

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