A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects with Front-line Advanced NSCLC and Other Selected Indications

Condition studied

Non-small cell lung cancer (NSCLC)

Investigational medicinal product(s)

Eligibility

Primary endpoint

ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per blinded independent central review (BICR).

Endpoint detail

PFS is the time from randomization until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first., ORR is the proportion of subjects with confirmed CR or confirmed PR per BICR., OS is the time from randomization until death due to any cause., Safety including but not limited to: TEAEs, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE v5.0 except for CRS, which will be graded according to the ASTCT guidelines., Incidence of STK-012 antibodies and qualitative assessment of safety outcomes., PK characterization of STK-012 (eg, AUC, Cmax, Tmax, t1/2).