RecruitingPhase 1NCT07027514

A Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer

A Phase 1b, Two-Part Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer


Sponsor

Ankyra Therapeutics, Inc

Enrollment

60 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Cohort A will enroll participants who have progressed on prior standard of care treatment with an anti-PD-1/PD-L1 antibody and a platinum-based chemotherapy regimen. Cohort B will enroll participants who are treatment-naïve for locally advanced or metastatic NSCLC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called Tolododekin Alfa (ANK-101), given alongside an existing immunotherapy drug, in people with advanced non-small cell lung cancer (a common type of lung cancer that has spread). **You may be eligible if:** - You have been diagnosed with locally advanced or metastatic non-small cell lung cancer - You have measurable tumors on imaging scans - You are in good physical health and expected to live more than 12 weeks - Your thyroid hormone levels and heart function are normal - You are willing to use effective contraception **You may NOT be eligible if:** - You have received prior immunotherapy treatment - You have a serious heart condition or significantly prolonged heart rhythm - You have active autoimmune disease requiring treatment - You are pregnant or breastfeeding - You have active brain metastases that are untreated or unstable 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGtolododekin alfa

Participants will receive tolododekin alfa as an intratumoral injection every 3 weeks (Q3W).

DRUGCetrelimab

Participants will receive cetrelimab Q3W.


Locations(5)

Community Health Network

Indianapolis, Indiana, United States

Barbara Ann Karmanos Cancer Hospital

Detroit, Michigan, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

FirstHealth of the Carolinas

Pinehurst, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07027514


Related Trials