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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 · Ankyra Therapeutics, Inc
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Official title
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
About this study
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 criteria
Inclusion Criteria: 1. Have confirmed locally advanced or metastatic NSCLC 2. Thyroid-stimulating hormone (TSH) within normal limits 3. Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) 4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 5. Have a life expectancy \> 12 weeks 6. Have baseline electrocardiogram (ECG) without evidence of acute ischemia or prolonged QT interval 7. Heterosexually active women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception 8. Male participants who are not sterile must commit to the use of a reliable method of birth control or abstinence 9. Human immunodeficiency virus (HIV)-infected participants must be on anti-retroviral therapy (ART) and have well-controlled HIV infection/disease 10. Resolution of all prior anticancer therapy toxicities prior to C1D1. 11. Willingness to provide fresh tumor biopsy specimens 12. Capable of understanding and complying with protocol requirements 13. Provides written informed consent for the study Exclusion Criteria: 1. Cohort A only: Participants with toxic effects to manage adverse events from previous treatment with immunotherapy 2. Cohort B only: Prior therapy with an immune checkpoint inhibitor. 3. Have known EGFR or ALK mutations 4. Have had prior treatment with recombinant interleukin-12 (IL-12) 5. Have received short-term systemic therapy with immunosuppressive agents prior to C1D1 6. Have active autoimmune disease or medical conditions requiring chronic steroid or other immunosuppressive therapy prior to C1D1 7. Have received live vaccines prior to C1D1 8. Have primary or acquired immunodeficient states 9. Female participant who is pregnant or breastfeeding 10. Have a history of allogeneic tissue/solid organ transplant 11. Has active hepatitis B virus (HBV) or hepatitis C virus (HCV). 12. HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease 13. Have known active central nervous system metastases 14. Have congestive heart failure, active coronary artery disease, unevaluated new onset angina, unstable angina, or clinically significant cardiac arrhythmias. 15. Have uncontrolled bleeding disorders prior to C1D1 16. Participants on coumadin (warfarin), due to potential for increased bleeding risk associated with surgery 17. History of noninfectious pneumonitis 18. Cohort A only: History of allergy to protein-based therapies, history of any significant drug allergy, or known allergies, hypersensitivity, or intolerance to cetrelimab excipients OR Cohort B only: Hypersensitivity to any component of the anti-PD-1/PD-L1 antibody selected as standard of care 19. Have other systemic conditions or organ abnormalities that may interfere with the conduct of the study 20. Have any acute or chronic psychiatric problems or substance abuse disorder that make the participant unsuitable for participation
Study design
Enrollment target: 60 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-22
Estimated completion: 2028-12-31
Last updated: 2026-09-02
Interventions
Drug: tolododekin alfaDrug: Cetrelimab
Primary outcomes
  • Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (6 months)
Sponsor
Ankyra Therapeutics, Inc · industry
Contacts & investigators
ContactAnkyra Therapeutics · contact · LANTERN@ankyratx.com · 7817185121
All locations (11)
University of MiamiRecruiting
Coral Gables, Florida, United States
Mayo ClinicRecruiting
Jacksonville, Florida, United States
OSF Healthcare System; Saint Francis Medical CenterRecruiting
Peoria, Illinois, United States
Community Health NetworkRecruiting
Indianapolis, Indiana, United States
Barbara Ann Karmanos Cancer HospitalWithdrawn
Detroit, Michigan, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Roswell Park Comprehensive Cancer CenterRecruiting
Buffalo, New York, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
FirstHealth of the CarolinasRecruiting
Pinehurst, North Carolina, United States
Thomas Jefferson UniversityRecruiting
Philadelphia, Pennsylvania, United States
Vanderbilt UniversityRecruiting
Nashville, Tennessee, United States
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 · TrialPath