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

Phase 2RecruitingNCT05098132

Synthekine364 enrolled

Overview

This is a phase 1/2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative, non-squamous, non-small cell lung cancer.

Phase 1 \[closed to enrollment\]: The phase 1a portion is a dose escalation study to evaluate STK-012 as monotherapy and in combination therapy in patients with selected solid tumors. The phase 1b portion is a dose expansion study to evaluate STK-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types. Phase 2 \[open to enrollment\]: The phase 2 portion is a randomized, open label study to evaluate STK-012 at two dose levels in combination with standard of care (SoC) pembrolizumab, pemetrexed and carboplatin, versus SoC, in patients with first line, PD-L1 negative, non-squamous, non-small cell lung cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

364

Conditions

Advanced Solid Tumor Non Small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Selected Inclusion Criteria: 1. Phase 1 \[closed to enrollment\] 2. Phase 2 \[open to enrollment\]: * Diagnosis of non-small cell lung cancer (NSCLC). * Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment. * Non-squamous (NSQ) cell histology. * No prior systemic therapy for advanced/metastatic NSQ NSCLC. * Tumor is PD-L1 negative (TPS \<1%) by local testing. * No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy. Selected Exclusion Criteria: 1. Phase 1 \[closed to enrollment\] 2. Phase 2 \[open to enrollment\]: * Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment * Tumor with small cell, neuroendocrine, or sarcomatoid components. * Received radiotherapy ≤ 7 days of the first dose of study treatment. * Known untreated central nervous system metastases * Any history of carcinomatous meningitis

Locations (27)

University of Arizona Cancer Center

Tucson, Arizona, United States

RECRUITING

Beverly Hills Cancer Center

Beverly Hills, California, United States

RECRUITING

Providence Medical Foundation

Fullerton, California, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, United States

Outcomes

Primary Outcomes

Phase 1a: Treatment emergent adverse events (TEAEs)

Incidence of TEAEs in participants with select advanced solid tumors

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

Phase 1a: Serious adverse events (SAEs)

Incidence of SAEs in participants with select advanced solid tumors

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

Phase 1a: Dose limiting toxicities (DLTs)

Incidence of DLTs in participants with select advanced solid tumors

Time frame: Cycle 1, Days 1 through 21

Phase 1a: Deaths

Incidence of death in participants with select advanced solid tumors

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

Phase 1b: TEAEs at the RP2D

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

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

Phase 1b: SAEs at the RP2D

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

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

Phase 1b: Deaths at the RP2D

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

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

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

To compare the ORR in 1L PD-L1 negative NSQ NSCLC 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.

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

Secondary Outcomes

Phase 1: ORR

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.

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

Phase 1: Progression free survival (PFS)

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

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

Phase 1: Overall survival (OS)

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

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

Phase 1/2: STK-012 ADAs

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

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

Phase 1/2: AUC of STK-012

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

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

Phase 1/2: Cmax of STK-012

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

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

Phase 1/2: Tmax of STK-012

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

Phase 2: PFS in Arm A versus Arm C

To compare the PFS in 1L PD-L1 negative NSQ NSCLC 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.

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

Phase 2: ORR in Arm B versus Arm C

To compare the ORR in 1L PD-L1 negative NSQ NSCLC 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.

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

Phase 2: PFS in Arm B versus Arm C

To compare the PFS in 1L PD-L1 negative NSQ NSCLC 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.

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

Phase 2: OS in Arm A versus C

To compare the OS in 1L PD-L1 negative NSQ NSCLC 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.

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

Phase 2: OS in Arm B versus C

To compare the OS in 1L PD-L1 negative NSQ NSCLC 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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (27)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts