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

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.

NCT Number	NCT06171750
Lead Sponsor	Ankyra Therapeutics, Inc
Conditions	Advanced Solid Tumor, Cutaneous Tumor, Subcutaneous Tumor, Malignant Solid Tumor, Solid Tumor, Metastatic Solid Tumor, Metastasis to Soft Tissue, Non Small Cell Lung Cancer +1 more
Enrollment	97 participants
Start Date	2024-01-19
Primary Completion	2027-04 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-03-06