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A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors

Colorectal Neoplasms
Clinicaltrials.gov:
EU CTIS:
#2025-521535-36-00
Other:
#95437446LUC1001
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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

Note: The criteria listed here are only a general guide. To join any trial, you must first have a medical check by a qualified doctor or healthcare professional. They will decide if the trial is a good fit and safe for your health.
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