A Phase 1 Study of JNJ-95437446 in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer, Colorectal Cancer, or Head and Neck Squamous Cell Carcinoma

The primary objective of this phase 1 study is to evaluate the safety and pharmacokinetics of JNJ-95437446 in patients presenting with locally advanced, metastatic non-small cell lung cancer, colorectal cancer, or head and neck squamous cell carcinoma that has progressed following standard of care therapy. Determining the safety profile and drug disposition is essential for establishing the therapeutic index in patients with advanced-stage solid tumors.

The study population consists of 328 patients, including both males and females, aged between 18 and 64 years. The participants are diagnosed with non-small cell lung cancer, colorectal cancer, or head and neck squamous cell carcinoma that is either locally advanced or metastatic. Inclusion is limited to individuals whose disease has recurred or progressed following previous standard of care therapy. The sponsor did not provide information regarding lifestyle considerations or specific selection methodologies.

This Phase 1 study evaluates the safety and pharmacology of JNJ-95437446 in individuals with locally advanced or metastatic non-small cell lung cancer, colorectal cancer, or head and neck squamous cell carcinoma that has progressed following standard of care therapy. The research methodology involves a systematic sequence of clinical assessments. The process begins with a screening visit to determine eligibility based on specific inclusion and exclusion criteria. Subsequent follow-up visits are scheduled to monitor clinical responses and potential adverse events. The protocol concludes with an end-of-study visit to finalize data collection. Participation continues for a duration determined by individual clinical progress and safety requirements. Early termination from the study may occur if specific medical or safety criteria are met.

The assessment of efficacy in this Phase 1 clinical trial involves evaluating patients with locally advanced, metastatic non-small cell lung cancer, colorectal cancer, or head and neck squamous cell carcinoma that has recurred or progressed following standard of care therapy.