A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
- Advanced Stage Solid Tumors
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 400
- Started
- 15 July 2025
- Main results due
- 18 November 2027
- Study sites
- 10
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(10)
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
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
Showing 10 of 10 sites. 10 of the 10 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07107230. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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