Phase 1 Study of Tolododekin Alfa ANK-101 Safety and Tolerability in Advanced Solid Tumors with or without Cemiplimab

What this Trial Is About

Researchers are evaluating the safety and tolerability of tolododekin alfa ANK-101 injected directly into tumors in adults with advanced solid tumors who have not responded to standard treatments or cannot benefit from them. This Phase 1, open-label, dose escalation study aims to determine the best dose of ANK-101 and its effects alone or combined with cemiplimab in different types of tumors, including superficial, visceral, and cutaneous squamous cell carcinoma CSCC. The study is divided into three parts. In Part 1, participants with accessible superficial tumors receive ANK-101 injections every three weeks. Part 2 enrolls participants with visceral tumors receiving ANK-101 injections with a dose expansion cohort for non-small cell lung cancer NSCLC. Part 3 involves combining ANK-101 with cemiplimab every three weeks for participants with high-risk locally advanced or metastatic CSCC. Participants may receive additional doses or cemiplimab monotherapy after completing the combination treatment phase. Participants undergo tumor biopsies when possible and are closely monitored for side effects, dose-limiting toxicities, and treatment responses. Safety assessments occur from the first dose through 90 days after the last injection. Pharmacokinetic and clinical activity measurements continue for up to two years. The study duration varies by participant depending on treatment response and tolerance, with assessments including physical exams, laboratory tests, and imaging to evaluate tumor changes and overall health.

Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors