Recruiting

Tolododekin Alfa (ANK-101) and Anti-PD-1/PD-L1 Antibody Combination Treatment for Advanced Non-Small Cell Lung Cancer

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Study Aim

This early-stage study examines how the combination of Tolododekin Alfa (ANK-101) and Anti-PD-1/PD-L1 antibody treatment affects advanced non-small cell lung cancer. The goal is to assess its impact on tumor shrinkage.

What is being tested

tolododekin alfa

+ Cetrelimab

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
+33 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorAnkyra Therapeutics, Inc
Study ContactAnkyra Therapeutics
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: October 22, 2025

Actual date on which the first participant was enrolled.

This study focuses on testing a new combination of treatments for people with advanced non-small cell lung cancer (NSCLC). It looks at the effects of a drug called tolododekin alfa (ANK-101) when used with another type of medicine that targets proteins known as PD-1 or PD-L1, which are involved in how cancer cells evade the immune system. There are two groups involved: one group includes patients whose cancer has worsened after receiving the usual treatments, and the other group includes patients who have not yet received treatment for their advanced lung cancer. The goal is to find out if this new combination can provide better outcomes for patients who have limited options. Participants will receive the treatments as part of the study to see how well they work together. The study observes how the body responds to this combination and checks for any potential improvements in controlling the cancer. Researchers will closely monitor participants to understand the safety and effects of these medications, ensuring that any risks are managed and any benefits are maximized. Although specific outcomes are not listed, the study aims to gather essential information to inform future treatments for lung cancer.

Official TitleA 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 
NCT07027514
Principal SponsorAnkyra Therapeutics, Inc
Study ContactAnkyra Therapeutics
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

13 inclusion criteria required to participate
Have confirmed locally advanced or metastatic NSCLC

Thyroid-stimulating hormone (TSH) within normal limits

Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1

Show More Criteria

20 exclusion criteria prevent from participating
Have known EGFR or ALK mutations

Have had prior treatment with recombinant interleukin-12 (IL-12)

Cohort A only: Participants with Grade 3 or higher toxic effects to manage adverse events from previous treatment with immunotherapy

Cohort B only: Prior therapy with an immune checkpoint inhibitor.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive up to 8 cycles of tolododekin alfa in combination with cetrelimab given for up to 1 year

Group II

Experimental
Participants will receive up to 8 cycles of tolododekin alfa in combination with the Investigator's choice of a Food and Drug Administration (FDA)-approved anti-PD-1/PD-L1 antibody given according to the FDA-approved label

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

Community Health Network

Indianapolis, United StatesSee the location
Recruiting

Barbara Ann Karmanos Cancer Hospital

Detroit, United States
Recruiting

Roswell Park Comprehensive Cancer Center

Buffalo, United States
Recruiting

Icahn School of Medicine at Mount Sinai

New York, United States
Recruiting
5 Study Centers