Recruiting
Phase 1

JNJ-95437446

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07107230

Conditions

Advanced Stage Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-95437446

Amivantamab

Study Details

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

Advanced Stage Solid Tumors

Study ID

NCT07107230

Start date

Jul 15, 2025

Status verified date

Aug, 2026

Completion date

Apr 24, 2028

Anticipated

Primary completion date

Nov 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JNJ-95437446

Participants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2 doses (RP2Ds) has been developed. In selected participants in Part 1, amivantamab may also be co-dosed with JNJ-95437446. Participants in Part 2 will receive JNJ-95437446 at the RP2Ds developed in Part 1.

Interventions

JNJ-95437446

JNJ-95437446 will be administered.

Amivantamab

Amivantamab will be administered.

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) by Severity [ Time Frame: Up to 2 years and 4 months ]
  • Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 21 days ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Columbia University Medical Center Herbert Irving Pavilion

Recruiting

New York, New York, United States, 10032

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

NEXT Oncology

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-09-01.