Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

Phase 1a: Treatment emergent adverse events (TEAEs)

Timeframe: From 1st dose of study treatment through 90 days after last dose

Incidence of TEAEs in participants with select advanced solid tumors

Phase 1a: Serious adverse events (SAEs)

Timeframe: From 1st dose of study treatment through 90 days after last dose

Incidence of SAEs in participants with select advanced solid tumors

Phase 1a: Dose limiting toxicities (DLTs)

Timeframe: Cycle 1, Days 1 through 21

Incidence of DLTs in participants with select advanced solid tumors

Phase 1a: Deaths

Timeframe: From 1st dose of study treatment until death, up to 4 years

Incidence of death in participants with select advanced solid tumors

Phase 1b: TEAEs at the RP2D

Timeframe: From 1st dose of study treatment through 90 days after last dose

Incidence of TEAEs at the recommended phase 2 dose (RP2D) in participants with select advanced solid tumors

Phase 1b: SAEs at the RP2D

Timeframe: From 1st dose of study treatment through 90 days after last dose

Incidence of SAEs at the RP2D in participants with select advanced solid tumors

Phase 1b: Deaths at the RP2D

Timeframe: From 1st dose of study treatment until death, up to 4 years

Incidence of death at the RP2D in participants with select advanced solid tumors

Phase 2: Overall response rate (ORR) in Arm A versus Arm C

Timeframe: From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years

To compare the ORR in 1L NSQ NSCLC (PD-L1\<1% or STK11m) subjects treated with STK-012 2.25 mg + SoC vs. SoC (Arms A vs. C). ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per BICR.

Phase 1: ORR

Timeframe: From enrollment until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years

Assessment of preliminary efficacy, specifically ORR, in select advanced solid tumors. ORR is the proportion of subjects with confirmed CR or confirmed PR per investigator assessment.

Phase 1: Progression free survival (PFS)

Timeframe: From enrollment until first documentation of disease progression per investigator assessment or death due to any cause, whichever occurs first, up to 4 years

Assessment of preliminary efficacy, specifically PFS, in select advanced solid tumors.

Phase 1: Overall survival (OS)

Timeframe: From enrollment until death due to any cause, up to 4 years

Assessment of preliminary efficacy, specifically OS, in select advanced solid tumors.

Phase 1/2: STK-012 ADAs

Timeframe: From screening through 30 days after last dose of STK-012

Anti-drug antibodies (ADA) to assess immunogenicity of STK-012 in advanced NSCLC and other select solid tumors.

Phase 1/2: AUC of STK-012

Timeframe: From screening through 30 days after last dose of STK-012

Area under the curve (AUC) to assess pharmacokinetic (PK) characterization of STK-012 in advanced NSCLC and other select solid tumors.

Phase 1/2: Cmax of STK-012

Timeframe: From screening through 30 days after last dose of STK-012

Maximum concentration (Cmax) to assess PK characterization of STK-012 in advanced NSCLC and other select solid tumors.

Phase 1/2: Tmax of STK-012

Timeframe: From screening through 30 days after last dose of STK-012

Time of maximum concentration (Tmax) to assess PK characterization of STK-012 in advanced NSCLC and other select solid tumors.

Phase 1/2: Half life of STK-012

Timeframe: From screening through 30 days after last dose of STK-012

Half life (t1/2) to assess PK characterization of STK-012 in advanced NSCLC and other select solid tumors.

Phase 2: PFS in Arm A versus Arm C

Timeframe: From randomization until first documentation of disease progression per BICR or death due to any cause, whichever occurs first, up to 4 years

To compare the PFS in 1L NSQ NSCLC (PD-L1\<1% or STK11m) subjects treated with STK-012 2.25 mg + SoC vs. SoC (Arms A vs. C). PFS is the time from randomization until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first.

Phase 2: ORR in Arm B versus Arm C

Timeframe: From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years

To compare the ORR in 1L NSQ NSCLC (PD-L1\<1% or STK11m) subjects treated with STK-012 1.5 mg + SoC vs. SoC (Arms B vs. C). ORR is the proportion of subjects with confirmed CR or confirmed PR per BICR.

Phase 2: PFS in Arm B versus Arm C

Timeframe: From randomization until first documentation of disease progression per BICR or death due to any cause, whichever occurs first, up to 4 years

To compare the PFS in 1L NSQ NSCLC (PD-L1\<1% or STK11m) subjects treated with STK-012 1.5 mg + SoC vs. SoC (Arms B vs. C). PFS is the time from randomization until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first.

Phase 2: OS in Arm A versus C

Timeframe: From randomization until death due to any cause, up to 4 years

To compare the OS in 1L NSQ NSCLC (PD-L1\<1% or STK11m) subjects treated with STK-012 2.25 mg + SoC vs. SoC (Arms A vs. C). OS is the time from randomization until death due to any cause.

Phase 2: OS in Arm B versus C

Timeframe: From randomization until death due to any cause, up to 4 years

To compare the OS in 1L NSQ NSCLC (PD-L1\<1% or STK11m) subjects treated with STK-012 1.5 mg + SoC vs. SoC (Arms B vs. C). OS is the time from randomization until death due to any cause.

Phase 2: TEAEs

Timeframe: From 1st dose of study treatment through 90 days after last dose

Incidence of TEAEs in 1L NSQ NSCLC (PD-L1\<1% or STK11m)

Phase 2: SAEs

Timeframe: From 1st dose of study treatment through 90 days after last dose

Incidence of SAEs in 1L NSQ NSCLC (PD-L1\<1% or STK11m)

Phase 2: Deaths

Timeframe: From 1st dose of study treatment until death, up to 4 years

Incidence of death in 1L NSQ NSCLC (PD-L1\<1% or STK11m)