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 AimThis 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

Non Small Cell Lung Cancer

Over 18 Years
+33 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorAnkyra Therapeutics, Inc
Study ContactAnkyra Therapeutics
Last updated: October 9, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 30, 2025Actual 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 
Principal SponsorAnkyra Therapeutics, Inc
Study ContactAnkyra Therapeutics
Last updated: October 9, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Non Small Cell Lung Cancer
Criteria
13 inclusion criteria required to participate
Provides written informed consent for the study
Capable of understanding and complying with protocol requirements
Willingness to provide fresh tumor biopsy specimens
Resolution of all prior anticancer therapy toxicities to ≤ Grade 1 prior to C1D1.

Show More Criteria

20 exclusion criteria prevent from participating
Has known active uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV).
HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
Have active autoimmune disease or medical conditions requiring chronic steroid or other immunosuppressive therapy prior toC1D1
Have received short-term systemic therapy with immunosuppressive agents prior to C1D1

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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

Percentage of participants with complete response (CR) or partial response (PR) among all response evaluable participants
Secondary Objectives

Number of participants with adverse events (TEAEs, SAEs)

Time from first CR/PR to the date of progressive disease (PD) or death.

The percentage of participants with stable disease, complete response or partial response among all response evaluable participants

The duration from the first dose of tolododekin alfa until PD/death

The length of time participants remain alive starting from the first dose of tolododekin alfa

Measure response in injected and noninjected lesions

Characterize pharmacokinetic (PK) parameter AUC after IT injection of tolododekin alfa

Characterize pharmacokinetic (PK) parameter Cmax after IT injection of tolododekin alfa

Characterize pharmacokinetic (PK) parameter Tmax after IT injection of tolododekin alfa

Characterize pharmacokinetic (PK) parameter Vd/F after IT administration of tolododekin alfa

Characterize pharmacokinetic (PK) parameter t1/2 after IT administration of tolododekin alfa

Quantification of ADAs after IT administration of tolododekin alfa

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 1 location
Recruiting
Icahn School of Medicine at Mount SinaiNew York, United StatesSee the location
Recruiting
One Study Center