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
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
Ankyra Therapeutics, Inc
60 participants
Oct 22, 2025
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria13
- 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
Exclusion Criteria20
- 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
- Participants on coumadin (warfarin), due to potential for increased bleeding risk associated with surgery
- History of noninfectious pneumonitis within the previous 5 years
- 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
- Have other systemic conditions or organ abnormalities that may interfere with the conduct of the study
- Have any acute or chronic psychiatric problems or substance abuse disorder that make the participant unsuitable for participation
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Interventions
Participants will receive tolododekin alfa as an intratumoral injection every 3 weeks (Q3W).
Participants will receive cetrelimab Q3W.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07027514