Phase 1 Study to Find the Safe Dose and Effects of KUP-101A Given by IV in Adults With Advanced Skin and Other Selected Cancers

What this Trial Is About

Researchers are evaluating KUP-101A in patients with selected advanced solid tumors such as cutaneous melanoma, mucosal melanoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma of skin, and basal cell carcinoma of skin. The study aims to find the maximum tolerated dose and the recommended Phase 2 dose of KUP-101A. It also seeks to assess the drugs safety, tolerability, pharmacokinetics, and pharmacodynamics while gathering initial data on its efficacy in these patients. Participants receive intravenous infusions of KUP-101A at various dose levels, progressing sequentially to determine the best dose for further study. There are multiple experimental dose levels ranging from dose level 1 to dose level 7. The study follows a non-randomized design without blinding. Treatment continues while monitoring for dose-limiting toxicities and adverse events. During the trial, participants undergo evaluations for adverse events, laboratory tests including hematology and clinical chemistry, urinalysis, and vital signs, as well as 12-lead ECG monitoring. Pharmacokinetic parameters such as drug concentration and elimination half-life are measured up to three weeks, with safety assessments extending to three months after the last dose. The total participation timeline includes enrollment, treatment, and follow-up periods for safety and pharmacodynamic assessments.

A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors