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

Summary

This is a Phase 1, multicenter, open-label dose escalation study to determine the safety and tolerability of intratumoral (IT) injection of tolododekin alfa (ANK-101) in participants with advanced solid tumors who have progressed during or after receiving standard of care (SOC) therapy or who will not benefit from such therapy. The study will be conducted in three parts; in Part 1, participants with superficial lesions will receive ANK-101 as a single agent; in Part 2, participants with visceral lesions will receive ANK-101 as a single agent; and in Part 3, participants with cutaneous squamous cell carcinoma (CSCC) will receive ANK-101 in combination with cemiplimab.

Timeline

Start

2024-01-19

Primary completion

2027-04

Completion

2027-06

Publications

• Park JC, Curti B, Butler M, Wehrenberg-Klee E, Elassal J, Tighe R, Battula S, Iodice G, Kaufman HL, Kirkwood JM. Interleukin-12 anchored drug conjugate (tolododekin alfa) in patients with advanced solid tumors: first-in-human Phase 1 trial. Nat Commun. 2025 Sep 29;16(1):8567. doi: 10.1038/s41467-025-63579-9.

Drugs

Indications