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.
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
Cohort A only: Participants with 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)
Parallel
tolododekin alfa
DrugParticipants will receive tolododekin alfa as an intratumoral injection every 3 weeks (Q3W).
Cetrelimab
DrugParticipants will receive cetrelimab Q3W.
Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Percentage of participants with complete response (CR) or partial response (PR) among all response evaluable participants
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of participants with adverse events (TEAEs, SAEs)
Duration of Response (DoR)
Time from first CR/PR to the date of progressive disease (PD) or death.
Disease Control Rate (DCR)
The percentage of participants with stable disease, complete response or partial response among all response evaluable participants
Progression Free Survival (PFS)
The duration from the first dose of tolododekin alfa until PD/death
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