Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
NCT ID: NCT05098132
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
364 participants
INTERVENTIONAL
2022-01-25
2029-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1a: STK-012 monotherapy dose escalation
STK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications
STK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
Phase 1a: STK-012 + pembrolizumab dose escalation
STK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications
STK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
pembrolizumab
anti-PD-1 monoclonal antibody
Phase 1a: STK-012 + standard of care (SoC) dose escalation
STK-012 SC + SoC IV in first-line non-squamous (NSQ) NSCLC
STK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
pembrolizumab
anti-PD-1 monoclonal antibody
pemetrexed
chemotherapy
carboplatin
chemotherapy
Phase 1b: STK-012 monotherapy expansion
STK-012 SC monotherapy in selected solid tumor indications
STK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
Phase 1b: STK-012 + pembrolizumab dose expansion
STK-012 SC will be administered in combination with pembrolizumab IV in selected solid tumor indications
STK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
pembrolizumab
anti-PD-1 monoclonal antibody
Phase 1b: STK-012 + SoC dose expansion
STK-012 SC + SoC IV in first-line PD-L1 negative NSQ NSCLC
STK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
pembrolizumab
anti-PD-1 monoclonal antibody
pemetrexed
chemotherapy
carboplatin
chemotherapy
Phase 2: Arm A
STK-012 2.25 mg SC Q3W + SoC IV in first-line PD-L1 negative NSQ NSCLC
STK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
pembrolizumab
anti-PD-1 monoclonal antibody
pemetrexed
chemotherapy
carboplatin
chemotherapy
Phase 2: Arm B
STK-012 1.5 mg SC Q3W + SoC IV in first-line PD-L1 negative NSQ NSCLC
STK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
pembrolizumab
anti-PD-1 monoclonal antibody
pemetrexed
chemotherapy
carboplatin
chemotherapy
Phase 2: Arm C
SoC IV in first-line PD-L1 negative NSQ NSCLC
pembrolizumab
anti-PD-1 monoclonal antibody
pemetrexed
chemotherapy
carboplatin
chemotherapy
Interventions
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STK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
pembrolizumab
anti-PD-1 monoclonal antibody
pemetrexed
chemotherapy
carboplatin
chemotherapy
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Synthekine
INDUSTRY
Responsible Party
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Locations
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University of Arizona Cancer Center
Tucson, Arizona, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
Providence Medical Foundation
Fullerton, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
Yale New Haven Hospital, Yale Cancer Center
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States
Northwell Health
Lake Success, New York, United States
NYU Langone Health
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Baptist Memorial Hospital Cancer Center
Memphis, Tennessee, United States
Sarah Cannon Research Institute - Nashville
Nashville, Tennessee, United States
Renovatio Clinical
El Paso, Texas, United States
Oncology Consultants
Houston, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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STK-012-101
Identifier Type: -
Identifier Source: org_study_id
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