Actively Recruiting
A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
380
Participants Needed
9
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying JNJ-95437446 in adults with advanced solid tumors, including non-small cell lung cancer, colorectal carcinoma, and head and neck squamous cell carcinoma. The purpose is to find the recommended phase 2 doses and to evaluate the safety of those doses. This is a phase 1 study sponsored by Janssen Research & Development, LLC focusing on participants with measurable or evaluable disease and good performance status. Participants in Part 1 will receive JNJ-95437446 until at least two recommended phase 2 doses are developed. In Part 2, participants will receive the recommended doses identified in Part 1. The treatment involves administration of the drug JNJ-95437446, with no placebo or comparison groups mentioned. During the study, participants will undergo assessments to monitor adverse events, dose-limiting toxicities, and response to treatment using criteria such as RECIST v1.1. Blood samples will be collected to measure drug concentrations and antibody responses. Safety will be monitored for up to two years and four months. Participants will have regular evaluations including performance status and organ function checks throughout the study.
CONDITIONS
Brief Title
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed unresectable, locally advanced, or metastatic non-small cell lung cancer, colorectal carcinoma, or head and neck squamous cell carcinoma
- Participants with NSCLC adenocarcinoma and colorectal cancer must have molecular testing for EGFR and KRAS/NRAS/BRAF mutation status
- Have measurable or evaluable disease (Part 1: either; Part 2: at least one measurable lesion per RECIST v1.1)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening
- Appropriate hematologic, renal, and hepatic function within required limits
You will not qualify if you...
- Prior history of interstitial lung disease or pneumonitis requiring systemic steroids
- Unresolved toxicity from prior anticancer therapy greater than Grade 1
- Active viral, bacterial, or fungal infection requiring treatment within 7 days before first dose
- Clinically significant cardiovascular disease within 6 months prior to consent
- Prior or concurrent second malignancy likely to interfere with study endpoints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until at least two recommended phase 2 doses (RP2Ds) are developed in Part 1, and continued treatment in Part 2
Participants receive the study drug JNJ-95437446 in sequential parts, starting with dose finding in Part 1 followed by treatment at recommended doses in Part 2.
Visits as scheduled during treatment cycles
Duration - Up to 2 years and 4 months
Participants are monitored for safety and treatment response after completing treatment.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 9 locations
1
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
2
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
4
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
5
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
6
Hosp Univ Vall D Hebron
Barcelona, Spain, 8035
Actively Recruiting
7
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
8
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
9
Hosp Univ Hm Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here