Tolododekin alfa (ANK-101) plus anti-PD-1/PD-L1 antibody for advanced non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial combines tolododekin alfa (ANK-101) with an anti-PD-1/PD-L1 antibody (cetrelimab) in participants with locally advanced or metastatic NSCLC. The study enrolls two cohorts: Cohort A includes patients who progressed after prior anti-PD-1/PD-L1 therapy plus platinum-based chemotherapy, and Cohort B includes treatment-naïve patients. Primary Phase 1 goals focus on safety, tolerability, dose selection, and preliminary anti-tumor activity measured by RECIST v1.1, with required baseline measures such as ECG, TSH, measurable disease, ECOG 0–1, and a fresh tumor biopsy. The trial is being conducted at multiple U.S. cancer centers and requires regular on-site visits for treatment and monitoring.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Miami
  Coral Gables, Florida, United States Recruiting
• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• OSF Healthcare System; Saint Francis Medical Center
  Peoria, Illinois, United States Recruiting
• Community Health Network
  Indianapolis, Indiana, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Roswell Park Comprehensive Cancer Center
  Buffalo, New York, United States Recruiting

Study contacts

• Study coordinator: Ankyra Therapeutics
• Email: LANTERN@ankyratx.com
• Phone: 7817185121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.