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Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
Sponsor: Synthekine
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
364
Start Date
2022-01-25
Completion Date
2029-01
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
STK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
pembrolizumab
anti-PD-1 monoclonal antibody
pemetrexed
chemotherapy
carboplatin
chemotherapy
Locations (27)
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