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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 1

Conditions: Colorectal Neoplasms

Treatments: Drug: JNJ-95437446

Study type: Interventional

Funder types: Industry

Identifiers

NCT07107230

2025-521535-36-00 (Registry Identifier)

95437446LUC1001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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380 participants in 1 patient group

JNJ-95437446

Experimental group

Description:

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.

Treatment:

Drug: JNJ-95437446