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RecruitingInterventionalPhase 1

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

NCT ID: NCT07027514Sponsor: Ankyra Therapeutics, IncLast updated: 2025-11-18

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.

Arms & interventions

  • Drugtolododekin alfa

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

  • DrugCetrelimab

    Participants will receive cetrelimab Q3W.

Outcome measures

Primary

  • 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

    Time frame: 6 months

Secondary

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

    Time frame: 6 months

  • Duration of Response (DoR)

    Time frame: 6 months

  • Disease Control Rate (DCR)

    Time frame: 6 months

  • Progression Free Survival (PFS)

    Time frame: 6 months

  • Overall Survival (OS)

    Time frame: 6 months

  • Lesion-level response in injected and noninjected lesions

    Time frame: 6 months

  • Measure of area under the plasma concentration-time curve (AUC) of tolododekin alfa

    Time frame: 6 months

  • Measure of maximum plasma concentration (Cmax) of tolododekin alfa

    Time frame: 6 months

  • Measure of time to maximum concentration (Tmax) of tolododekin alfa

    Time frame: 6 months

  • Measure of volume of distribution adjusted for bioavailability (Vd/F) of tolododekin alfa

    Time frame: 6 months

  • Measure of terminal half-life (t1/2) of tolododekin alfa

    Time frame: 6 months

  • Incidence of treatment-emergent anti-drug antibodies (ADA) of tolododekin alfa

    Time frame: 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 at least 2 forms of highly effective methods of contraception 8. All 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 to ≤ Grade 1 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 Grade 3 or higher 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 toC1D1 7. Have received live vaccines within 28 days prior to C1D1 8. Have primary or acquired immunodeficient states 9. Women of childbearing potential who has a positive serum pregnancy test prior to C1D1 or female participant who is breastfeeding 10. Have a history of allogeneic tissue/solid organ transplant 11. Has known active uncontrolled 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 within the previous 5 years 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 locations (5)

Community Health Network

Indianapolis, Indiana, 46256

Recruiting
Neil Shukla, M.D. · Contact
Neil Shukla, M.D. · Principal Investigator

Barbara Ann Karmanos Cancer Hospital

Detroit, Michigan, 48201

Recruiting
Tarik Hadid, M.D. · Contact
Tarik Hadid, M.D. · Principal Investigator

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

Recruiting
Prantesh Jain, M.D. · Contact
Prantesh Jain, M.D. · Principal Investigator

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Recruiting
Thomas Marron, M.D. · Contact
Thomas Marron, M.D. · Principal Investigator

FirstHealth of the Carolinas

Pinehurst, North Carolina, 28374

Recruiting
Michael Pritchett, D.O. · Contact
Michael Pritchett, D.O. · Principal Investigator