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A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Trial Status: active
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07107230.
Locations matching your search criteria
United States
Colorado
Aurora
UCHealth University of Colorado Hospital
Status: Approved
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationJanssen Research & Development, LLC