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A Phase I Open-Label, Dose Escalation Study of the Safety and Tolerability of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors (ANCHOR)
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.
Details
| Lead sponsor | Ankyra Therapeutics, Inc |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 97 |
| Start date | 2024-01-19 |
| Completion | 2027-06 |
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
- Cutaneous Squamous Cell Carcinoma
Interventions
- tolododekin alfa
- Cemiplimab
Primary outcomes
- Incidence and characteristics of DLTs (Parts 1 and 2 only) and TEAEs — From Day 1 to 90 days after last injection of ANK-101
Number and percentage of participants reporting each DLT or TEAE. - RDE of ANK-101 — Approximately 12 months
Defined based on the rate of DLTs and TEAEs - Incidence and characteristics of TEAEs of ANK-101 in combination with Cemiplimab according to NCI CTCAE v5.0 (Part 3 only) — From Day 1 to 90 days after last injection of ANK-101 in combination with Cemiplimab.
Number and percentage of participants reporting each TEAE.
Countries
United States, Canada