Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
SYNERGY-101
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
1 other identifier
interventional
364
1 country
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2022
Longer than P75 for phase_1
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2021
CompletedFirst Posted
Study publicly available on registry
October 28, 2021
CompletedStudy Start
First participant enrolled
January 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
March 18, 2026
March 1, 2026
6.9 years
October 6, 2021
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (8)
Phase 1a: Treatment emergent adverse events (TEAEs)
Incidence of TEAEs in participants with select advanced solid tumors
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
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
Cycle 1, Days 1 through 21
Phase 1a: Deaths
Incidence of death in participants with select advanced solid tumors
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
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
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
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.
From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years
Secondary Outcomes (16)
Phase 1: ORR
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)
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)
From enrollment until death due to any cause, up to 4 years
Phase 1/2: STK-012 ADAs
From screening through 30 days after last dose of STK-012
Phase 1/2: AUC of STK-012
From screening through 30 days after last dose of STK-012
- +11 more secondary outcomes
Study Arms (9)
Phase 1a: STK-012 monotherapy dose escalation
EXPERIMENTALSTK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications
Phase 1a: STK-012 + pembrolizumab dose escalation
EXPERIMENTALSTK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications
Phase 1a: STK-012 + standard of care (SoC) dose escalation
EXPERIMENTALSTK-012 SC + SoC IV in first-line non-squamous (NSQ) NSCLC
Phase 1b: STK-012 monotherapy expansion
EXPERIMENTALSTK-012 SC monotherapy in selected solid tumor indications
Phase 1b: STK-012 + pembrolizumab dose expansion
EXPERIMENTALSTK-012 SC will be administered in combination with pembrolizumab IV in selected solid tumor indications
Phase 1b: STK-012 + SoC dose expansion
EXPERIMENTALSTK-012 SC + SoC IV in first-line PD-L1 negative NSQ NSCLC
Phase 2: Arm A
EXPERIMENTALSTK-012 2.25 mg SC Q3W + SoC IV in first-line PD-L1 negative NSQ NSCLC
Phase 2: Arm B
EXPERIMENTALSTK-012 1.5 mg SC Q3W + SoC IV in first-line PD-L1 negative NSQ NSCLC
Phase 2: Arm C
ACTIVE COMPARATORSoC IV in first-line PD-L1 negative NSQ NSCLC
Interventions
chemotherapy
chemotherapy
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
anti-PD-1 monoclonal antibody
Eligibility Criteria
You may qualify if:
- Phase 1 \[closed to enrollment\]
- 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.
You may not qualify if:
- Phase 1 \[closed to enrollment\]
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Synthekinelead
Study Sites (27)
University of Arizona Cancer Center
Tucson, Arizona, 85721, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404, United States
Yale New Haven Hospital, Yale Cancer Center
New Haven, Connecticut, 06510, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101, United States
Northwell Health
Lake Success, New York, 11042, United States
NYU Langone Health
New York, New York, 10016, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Baptist Memorial Hospital Cancer Center
Memphis, Tennessee, 38120, United States
Sarah Cannon Research Institute - Nashville
Nashville, Tennessee, 37203, United States
Renovatio Clinical
El Paso, Texas, 79915, United States
Oncology Consultants
Houston, Texas, 77303, United States
Renovatio Clinical
The Woodlands, Texas, 77380, United States
NEXT Virginia
Fairfax, Virginia, 22031, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2021
First Posted
October 28, 2021
Study Start
January 25, 2022
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share