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

NCT07027514 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ANK-101-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

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

  6 months

Secondary Outcomes (12)

• Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  6 months

• Duration of Response (DoR)

  6 months

• Disease Control Rate (DCR)

  6 months

• Progression Free Survival (PFS)

  6 months

• Overall Survival (OS)

  6 months

Study Arms (2)

Cohort A

EXPERIMENTAL

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

Drug: tolododekin alfa; Drug: Cetrelimab

Cohort B

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

Drug: tolododekin alfa

Interventions

tolododekin alfa DRUG

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

Cohort A; Cohort B

Cetrelimab DRUG

Participants will receive cetrelimab Q3W.

Cohort A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Have a life expectancy \> 12 weeks
• Have baseline electrocardiogram (ECG) without evidence of acute ischemia or prolonged QT interval
• Heterosexually active women of childbearing potential (WOCBP) must agree to use at least 2 forms of highly effective methods of contraception
• All male participants who are not sterile must commit to the use of a reliable method of birth control or abstinence
• Human immunodeficiency virus (HIV)-infected participants must be on anti-retroviral therapy (ART) and have well-controlled HIV infection/disease
• Resolution of all prior anticancer therapy toxicities to ≤ Grade 1 prior to C1D1.
• Willingness to provide fresh tumor biopsy specimens
• Capable of understanding and complying with protocol requirements
• Provides written informed consent for the study

You may not qualify if:

• 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.
• Have known EGFR or ALK mutations
• Have had prior treatment with recombinant interleukin-12 (IL-12)
• Have received short-term systemic therapy with immunosuppressive agents prior to C1D1
• Have active autoimmune disease or medical conditions requiring chronic steroid or other immunosuppressive therapy prior toC1D1
• Have received live vaccines within 28 days prior to C1D1
• Have primary or acquired immunodeficient states
• Women of childbearing potential who has a positive serum pregnancy test prior to C1D1 or female participant who is breastfeeding
• Have a history of allogeneic tissue/solid organ transplant
• 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 known active central nervous system metastases
• Have congestive heart failure, active coronary artery disease, unevaluated new onset angina, unstable angina, or clinically significant cardiac arrhythmias.
• Have uncontrolled bleeding disorders prior to C1D1

Sponsors & Collaborators

• Ankyra Therapeutics, Inc: lead

Study Sites (5)

Community Health Network

Indianapolis, Indiana, 46256, United States

RECRUITING

Barbara Ann Karmanos Cancer Hospital

Detroit, Michigan, 48201, United States

RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

FirstHealth of the Carolinas

Pinehurst, North Carolina, 28374, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Ankyra Therapeutics

CONTACT

7817185121; LANTERN@ankyratx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 18, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)