Ankyra Therapeutics, Inc
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.
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 a…
Participants will receive tolododekin alfa as an intratumoral injection every 3 weeks (Q3W).
Participants will receive cetrelimab Q3W.