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NCT07107230From ClinicalTrials.govRecruiting

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

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

  • Advanced Stage Solid Tumors

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
400
Started
15 July 2025
Main results due
18 November 2027
Study sites
10
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(10)

  • Florida Cancer Specialists

    Sarasota, Florida, United States

    Recruiting

  • Columbia University Medical Center Herbert Irving Pavilion

    New York, New York, United States

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, United States

    Recruiting

  • NEXT Oncology

    Fairfax, Virginia, United States

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, South Korea

    Recruiting

  • Samsung Medical Center

    Seoul, South Korea

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, Spain

    Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, Spain

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, Spain

    Recruiting

  • Hosp Univ Hm Sanchinarro

    Madrid, Spain

    Recruiting

Showing 10 of 10 sites. 10 of the 10 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07107230. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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