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
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
- Age range
- 18+ years
- Sex
- All
- Healthy 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…
Interventions
- Drugtolododekin alfa
Participants will receive tolododekin alfa as an intratumoral injection every 3 weeks (Q3W).
- DrugCetrelimab
Participants will receive cetrelimab Q3W.
Locations (5)
- Community Health NetworkIndianapolis, Indiana
- Barbara Ann Karmanos Cancer HospitalDetroit, Michigan
- Roswell Park Comprehensive Cancer CenterBuffalo, New York
- Icahn School of Medicine at Mount SinaiNew York, New York
- FirstHealth of the CarolinasPinehurst, North Carolina