A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Recruiting now · Phase 1
Conditions studied: Colorectal Neoplasms
In brief
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.
Key facts
- Study ID
- NCT07107230
- Run by
- Janssen Research & Development, LLC
- People needed
- 380
- Starts
- 2025-07-15
- Expected to finish
- 2028-04-24
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
- Columbia University Medical Center Herbert Irving Pavilion — New York, New York, United States (enrolling)
- Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
- NEXT Oncology — Fairfax, Virginia, United States (enrolling)
- Severance Hospital Yonsei University Health System — Seoul, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Hosp Univ Vall D Hebron — Barcelona, Spain (enrolling)
- Hosp Univ Fund Jimenez Diaz — Madrid, Spain (enrolling)
- Hosp. Univ. 12 de Octubre — Madrid, Spain (enrolling)
- Hosp Univ Hm Sanchinarro — Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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