Trials / Recruiting

RecruitingNCT06171750

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

Status: Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 97 (estimated)

Sponsor: Ankyra Therapeutics, Inc · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

This Phase 1 first-in-human (FIH) study will: 1) evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects and preliminary clinical activity of tolododekin alfa (ANK-101) administered as an intratumoral (IT) injection in participants with superficial or visceral lesions; 2) determine the recommended dose for expansion (RDE) of ANK-101; and 3) to determine the safety and tolerability of ANK-101 in combination with cemiplimab. For parts 1 and 2, the study design consists of six sequential dose-escalation cohorts. Part 1 will enroll participants with advanced solid tumors, with cutaneous, subcutaneous or nodal disease (accessible by clinical palpation or ultrasound guidance). Part 2 will start once the DLT period of dose level 1 in Part 1 is completed and dose level 2 is opened. Part 2 will enroll participants with visceral disease (accessible by interventional radiology or endoscopic techniques). Participants in Part 2 may also have superficial lesions that can be injected if in the Investigator's opinion this is clinically indicated. Ten participants with non-small cell lung cancer (NSCLC) will be dosed in a Part 2 dose expansion cohort at the RDE. Part 3 will start once dose escalation for Part 1 is complete and the RDE is identified. Part 3 will consist of ANK-101 in combination with cemiplimab in 15 participants with high-risk locally advanced or metastatic CSCC that have superficial lesions for injection. Participants will be treated with ANK-101 given as IT injections once every three weeks at the RDE in combination with cemiplimab. Enrollment in Part 3 will include a safety run-in of 5 participants. Following the first dose of the 5th participant, enrollment will pause for 21 days before opening enrollment to the remaining 10 participants or stopping further enrollment.

Conditions

Interventions

Type	Name	Description
DRUG	tolododekin 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.
DRUG	Cemiplimab	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.

Timeline

Start date: 2024-01-19
Primary completion: 2027-04-01
Completion: 2027-06-01
First posted: 2023-12-15
Last updated: 2026-03-06

Locations

5 sites across 2 countries: United States, Canada

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06171750. Inclusion in this directory is not an endorsement.