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
Summary
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.
Detailed description
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.
Arms & interventions
- DrugSTK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
- Drugpembrolizumab
anti-PD-1 monoclonal antibody
- Drugpemetrexed
chemotherapy
- Drugcarboplatin
chemotherapy
Outcome measures
Primary
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
Phase 1: ORR
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)
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)
Time frame: From enrollment until death due to any cause, up to 4 years
Phase 1/2: STK-012 ADAs
Time frame: From screening through 30 days after last dose of STK-012
Phase 1/2: AUC of STK-012
Time frame: From screening through 30 days after last dose of STK-012
Phase 1/2: Cmax of STK-012
Time frame: From screening through 30 days after last dose of STK-012
Phase 1/2: Tmax of STK-012
Time frame: From screening through 30 days after last dose of STK-012
Phase 1/2: Half life of STK-012
Time frame: From screening through 30 days after last dose of STK-012
Phase 2: PFS in Arm A versus Arm C
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
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
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
Time frame: From randomization until death due to any cause, up to 4 years
Phase 2: OS in Arm B versus C
Time frame: From randomization until death due to any cause, up to 4 years
Phase 2: TEAEs
Time frame: From 1st dose of study treatment through 90 days after last dose
Phase 2: SAEs
Time frame: From 1st dose of study treatment through 90 days after last dose
Phase 2: Deaths
Time frame: From 1st dose of study treatment until death, up to 4 years
Eligibility criteria
Study locations (27)
University of Arizona Cancer Center
Tucson, Arizona, 85721
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Providence Medical Foundation
Fullerton, California, 92835
UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404
Yale New Haven Hospital, Yale Cancer Center
New Haven, Connecticut, 06510
Georgetown University
Washington D.C., District of Columbia, 20057
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101
Northwell Health
Lake Success, New York, 11042
NYU Langone Health
New York, New York, 10016
Columbia University Irving Medical Center
New York, New York, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Duke Cancer Center
Durham, North Carolina, 27710
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Baptist Memorial Hospital Cancer Center
Memphis, Tennessee, 38120
Sarah Cannon Research Institute - Nashville
Nashville, Tennessee, 37203
Renovatio Clinical
El Paso, Texas, 79915
Oncology Consultants
Houston, Texas, 77303
Renovatio Clinical
The Woodlands, Texas, 77380
NEXT Virginia
Fairfax, Virginia, 22031
Northwest Medical Specialties
Tacoma, Washington, 98405