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Phase 1Recruiting

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

Sponsored by Ankyra Therapeutics, Inc

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.

Where this study is enrolling (10)

Show all 10 locations
Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.