Actively Recruiting
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
380
Participants Needed
9
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously diagnosed with histologically confirmed unresectable, locally advanced, or metastatic non-small cell lung cancer, colorectal carcinoma, or head and neck squamous cell carcinoma
- Local molecular testing for EGFR mutation in NSCLC adenocarcinoma or KRAS/NRAS/BRAF mutation in colorectal cancer
- Have measurable or evaluable disease (Part 1) or at least one measurable lesion per RECIST v1.1 (Part 2)
- 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...
- Any prior history of interstitial lung disease (ILD) or pneumonitis, including from anti-PD-1/PD-L1 therapy or radiation requiring systemic steroids
- Toxicity from prior anticancer therapy not resolved to Grade 311
- Active viral, bacterial, or fungal infection within 7 days before first study dose requiring systemic or non-topical treatment
- Clinically significant cardiovascular disease within 6 months before informed consent
- Prior or concurrent second malignancy that may interfere with study safety or efficacy endpoints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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