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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Participants will receive tolododekin alfa as an intratumoral injection every 3 weeks (Q3W).
Participants will receive cetrelimab Q3W.
Community Health Network
Indianapolis, Indiana, United States
RECRUITINGBarbara Ann Karmanos Cancer Hospital
Detroit, Michigan, United States
RECRUITINGRoswell Park Comprehensive Cancer Center
Buffalo, New York, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGFirstHealth of the Carolinas
Pinehurst, North Carolina, United States
RECRUITINGObjective 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
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of participants with adverse events (TEAEs, SAEs)
Time frame: 6 months
Duration of Response (DoR)
Time from first CR/PR to the date of progressive disease (PD) or death.
Time frame: 6 months
Disease Control Rate (DCR)
The percentage of participants with stable disease, complete response or partial response among all response evaluable participants
Time frame: 6 months
Progression Free Survival (PFS)
The duration from the first dose of tolododekin alfa until PD/death
Time frame: 6 months
Overall Survival (OS)
The length of time participants remain alive starting from the first dose of tolododekin alfa
Time frame: 6 months
Lesion-level response in injected and noninjected lesions
Measure response in injected and noninjected lesions
Time frame: 6 months
Measure of area under the plasma concentration-time curve (AUC) of tolododekin alfa
Characterize pharmacokinetic (PK) parameter AUC after IT injection of tolododekin alfa
Time frame: 6 months
Measure of maximum plasma concentration (Cmax) of tolododekin alfa
Characterize pharmacokinetic (PK) parameter Cmax after IT injection of tolododekin alfa
Time frame: 6 months
Measure of time to maximum concentration (Tmax) of tolododekin alfa
Characterize pharmacokinetic (PK) parameter Tmax after IT injection of tolododekin alfa
Time frame: 6 months
Measure of volume of distribution adjusted for bioavailability (Vd/F) of tolododekin alfa
Characterize pharmacokinetic (PK) parameter Vd/F after IT administration of tolododekin alfa
Time frame: 6 months
Measure of terminal half-life (t1/2) of tolododekin alfa
Characterize pharmacokinetic (PK) parameter t1/2 after IT administration of tolododekin alfa
Time frame: 6 months
Incidence of treatment-emergent anti-drug antibodies (ADA) of tolododekin alfa
Quantification of ADAs after IT administration of tolododekin alfa
Time frame: 6 months
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