At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Histologically or cytologically confirmed cutaneous, subcutaneous, soft tissue, or nodal advanced solid tumor; metastatic disease eligible
- ✓Measurable disease per RECIST v1.1 with tumor lesion ≥10 mm (≥15 mm short axis for lymph nodes)
- ✓Part 1: Tumor accessible for palpation or ultrasound-guided injection
- ✕Injectable tumors impinging on major airways or blood vessels
- ✕Prior treatment with recombinant IL-12
- ✕Systemic immunosuppressive therapy ≤28 days before treatment start
- ✕Live vaccines within 28 days before treatment start
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Open-Label, Dose Escalation Study of the Safety and Tolerability of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating tolododekin alfa and Cemiplimab for Advanced Solid Tumor and 8 related conditions. Currently recruiting, targeting 97 participants across 5 sites in 2 countries.
Signals
Detailed 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.
Study Details
Timeline
Interventions
IT administration of ANK-101 once every 3 weeks for up to 12 weeks (4 doses); if there is no disease progression, decrease in clinical performance status or unacceptable toxicity, participants may receive 4 additional doses of ANK-101.
Participants will receive four cycles of ANK-101 in combination with Cemiplimab. If there is no significant clinical deterioration as determined by the Investigator or unacceptable toxicity at Week 12, participants may receive an additional four cycles of the combination treatment. After stopping ANK-101 treatment, participants may stay on Cemiplimab monotherapy for an additional 24 weeks.