JNJ-95437446 for advanced-stage solid tumors
A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
This tests JNJ-95437446 to find a safe dose and check tolerability in people with advanced solid tumors, including colorectal cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 9 sites (Sarasota, Florida and 8 other locations) |
| Trial ID | NCT07107230 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with unresectable, locally advanced, or metastatic colorectal cancer (or specified NSCLC or head and neck cancers) who have ECOG 0–1, adequate organ function, and required molecular testing results.
Not a fit: Patients with ECOG ≥2, inadequate hematologic/renal/hepatic function, or who cannot provide required local molecular testing likely will not benefit from participation.
Why it matters
Potential benefit: If successful, this could identify a tolerable dose and safety profile that enables further testing and potentially offers a new treatment option for patients with advanced solid tumors.
How similar studies have performed: Dose-escalation and safety studies are a standard first step for new oncology drugs and similar targeted agents have shown benefit in molecularly selected cancers, but the efficacy of this specific compound is not yet established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sarasota, Florida and 8 other locations
- Florida Cancer Specialists — Sarasota, Florida, 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)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.