Actively Recruiting
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
Led by Ankyra Therapeutics, Inc · Updated on 2025-11-18
60
Participants Needed
5
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have confirmed locally advanced or metastatic NSCLC
- Thyroid-stimulating hormone (TSH) within normal limits
- Have measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
- Have a life expectancy greater than 12 weeks
- Have baseline electrocardiogram (ECG) without acute ischemia or prolonged QT interval
- Women of childbearing potential must use at least 2 highly effective contraception methods
- Male participants who are not sterile must use reliable birth control or abstinence
- HIV-infected participants must be on anti-retroviral therapy with well-controlled infection
- All prior anticancer therapy toxicities resolved to Grade 1 or less prior to first treatment
- Willingness to provide fresh tumor biopsy specimens
- Capable of understanding and complying with protocol requirements
- Provide written informed consent for the study
You will not qualify if you...
- Cohort A: Participants with Grade 3 or higher toxic effects from previous immunotherapy
- Cohort B: Prior therapy with an immune checkpoint inhibitor
- Known EGFR or ALK mutations
- Prior treatment with recombinant interleukin-12 (IL-12)
- Recent systemic immunosuppressive therapy before first treatment
- Active autoimmune disease or need for chronic steroid/immunosuppressive therapy before first treatment
- Received live vaccines within 28 days prior to first treatment
- Primary or acquired immunodeficiency
- Positive pregnancy test or breastfeeding in women of childbearing potential
- History of allogeneic tissue or organ transplant
- Active uncontrolled hepatitis B or C virus infection
- HIV-infected participants with Kaposi sarcoma or Multicentric Castleman Disease
- Active uncontrolled central nervous system metastases
- Congestive heart failure, active coronary artery disease, unstable angina, or significant arrhythmias
- Uncontrolled bleeding disorders prior to first treatment
- Use of coumadin (warfarin) due to bleeding risk
- History of noninfectious pneumonitis within past 5 years
- Cohort A: Allergy to protein-based therapies or cetrelimab excipients
- Cohort B: Hypersensitivity to any component of the anti-PD-1/PD-L1 antibody
- Other systemic conditions or organ problems interfering with study
- Acute or chronic psychiatric issues or substance abuse making participation unsuitable
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Community Health Network
Indianapolis, Indiana, United States, 46256
Actively Recruiting
2
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, United States, 48201
Actively Recruiting
3
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
5
FirstHealth of the Carolinas
Pinehurst, North Carolina, United States, 28374
Actively Recruiting
Research Team
A
Ankyra Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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