JNJ-95437446 for advanced-stage solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 interventional study uses a two-part design: Part 1 is dose escalation to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 and Part 2 further examines safety at those doses in participants with advanced solid tumors. Eligible participants have histologically confirmed unresectable, locally advanced, or metastatic colorectal cancer, non‑small cell lung cancer (adenocarcinoma), or head and neck squamous cell carcinoma, with measurable or evaluable disease and an ECOG performance status of 0–1. Local molecular testing for EGFR in NSCLC and KRAS/NRAS/BRAF in colorectal cancer is required, and safety will be monitored via adverse event reporting and laboratory assessments. The study is sponsored by Janssen and is conducted at several U.S. oncology centers, with primary objectives focused on dose selection and safety rather than demonstrating efficacy.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.