A Phase I Study to Evaluate the Safety and Efficacy of KUP-101A in Patients with Advanced Solid Tumors Including Cutaneous and Mucosal Melanoma and Squamous Cell Carcinoma

The primary objective is to evaluate the safety of KUP-101A in patients diagnosed with advanced solid tumors, including cutaneous melanoma, mucosal melanoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, or basal cell carcinoma. Assessing these parameters is critical to determining the tolerable dose levels and the potential toxicity profile of the investigational product in this patient population. 4, 5

The sponsor did not provide information regarding the total number of participants. The study population consists of patients experiencing advanced solid tumors, specifically including cutaneous melanoma, mucosal melanoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, or basal cell carcinoma. The cohort includes both males and females within the specified age range of 18 to 40 years.

This Phase 1 clinical trial is designed to evaluate the safety and effects of KUP-101A in individuals diagnosed with specific advanced solid tumors, including cutaneous melanoma, mucosal melanoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, or basal cell carcinoma. The research methodology involves a sequence of study visits beginning with a screening visit to assess eligibility. Following the initial assessment, participants will undergo scheduled follow-up visits to monitor clinical responses and safety profiles, concluding with an end-of-study visit. The total duration of the study is estimated to span from January 2026 to August 2027. Participation may be terminated early if predefined clinical conditions or safety criteria are met.

The assessment of efficacy in this Phase 1 clinical trial focuses on patients with advanced solid tumors, including cutaneous melanoma, mucosal melanoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, and basal cell carcinoma.