A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Recruiting · NCT07107230 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
JNJ-95437446
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
10 locations listed across 4 US states.
- Florida Cancer Specialists - Sarasota, Florida, United States
- Columbia University Medical Center Herbert Irving Pavilion - New York, New York, United States
- Tennessee Oncology - Nashville, Tennessee, United States
- NEXT Oncology - Fairfax, Virginia, United States
- Hosp Univ Vall D Hebron - Barcelona, Spain
- Hosp Univ Fund Jimenez Diaz - Madrid, Spain
- Hosp. Univ. 12 de Octubre - Madrid, Spain
- Hosp Univ Hm Sanchinarro - Madrid, Spain
- Severance Hospital Yonsei University Health System - Seoul, South Korea
- Samsung Medical Center - Seoul, South Korea