RecruitingPhase 1NCT06171750

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

A Phase I Open-Label, Dose Escalation Study of the Safety and Tolerability of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors

Sponsor

Ankyra Therapeutics, Inc

Enrollment

97 participants

Start Date

Jan 19, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Metastatic Solid Tumor Solid Tumor Cutaneous Tumor Subcutaneous Tumor Malignant Solid Tumor Metastasis to Soft Tissue

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called tolododekin alfa (ANK-101), which activates immune cells called NK cells to fight cancer, by injecting it directly into solid tumors in patients with advanced cancers of the skin, soft tissue, or nearby lymph nodes. **You may be eligible if...** - You are 18 or older - You have advanced solid tumors (cancer that has spread or cannot be removed), specifically involving the skin, soft tissue, or lymph nodes - You have at least one tumor large enough (10 mm or more) that can be reached for injection by palpation, ultrasound, CT scan, or other guided procedures - Standard treatment options are no longer working, are not tolerated, or you are not eligible for them - You are in good general health (ECOG 0-1) with at least 12 weeks life expectancy **You may NOT be eligible if...** - Your heart function tests show abnormalities (prolonged QTc) - Your blood, liver, or kidney function is inadequate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtolododekin alfa

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.

DRUGCemiplimab

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.