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New drug JNJ-95437446 enters human testing for Hard-to-Treat cancers

NCT ID NCT07107230

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 5 times

Summary

This early-stage trial tests a new drug called JNJ-95437446 in people with advanced solid tumors, including colorectal cancer, that have not responded to standard treatments. The study has two parts: first, finding a safe dose, and second, checking safety more closely in a larger group. About 380 participants will take part to see if the drug can shrink tumors and what side effects it may cause.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JNJ-95437446
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, not yet on effectiveness. The drug may cause side effects or not shrink tumors. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colorectal carcinoma colorectal neoplasm head and neck squamous cell carcinoma non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced stage solid tumors Colorectal neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Medical Center Herbert Irving Pavilion

    RECRUITING

    New York, New York, 10032, United States

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Hosp Univ Fund Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Hosp Univ Hm Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • Hosp Univ Vall D Hebron

    RECRUITING

    Barcelona, 8035, Spain

  • Hosp. Univ. 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • NEXT Oncology

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.