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
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.
Arms & interventions
- Drugtolododekin alfa
Participants will receive tolododekin alfa as an intratumoral injection every 3 weeks (Q3W).
- DrugCetrelimab
Participants will receive cetrelimab Q3W.
Outcome measures
Primary
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
Time frame: 6 months
Secondary
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: 6 months
Duration of Response (DoR)
Time frame: 6 months
Disease Control Rate (DCR)
Time frame: 6 months
Progression Free Survival (PFS)
Time frame: 6 months
Overall Survival (OS)
Time frame: 6 months
Lesion-level response in injected and noninjected lesions
Time frame: 6 months
Measure of area under the plasma concentration-time curve (AUC) of tolododekin alfa
Time frame: 6 months
Measure of maximum plasma concentration (Cmax) of tolododekin alfa
Time frame: 6 months
Measure of time to maximum concentration (Tmax) of tolododekin alfa
Time frame: 6 months
Measure of volume of distribution adjusted for bioavailability (Vd/F) of tolododekin alfa
Time frame: 6 months
Measure of terminal half-life (t1/2) of tolododekin alfa
Time frame: 6 months
Incidence of treatment-emergent anti-drug antibodies (ADA) of tolododekin alfa
Time frame: 6 months
Eligibility criteria
Study locations (5)
Community Health Network
Indianapolis, Indiana, 46256
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, 48201
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
FirstHealth of the Carolinas
Pinehurst, North Carolina, 28374