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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 25, 2022
Primary Completion Date
January 1, 2029
Completion Date
January 1, 2029
Last Updated
March 18, 2026
364
ESTIMATED participants
STK-012
DRUG
pembrolizumab
DRUG
pemetrexed
DRUG
carboplatin
DRUG
Lead Sponsor
Synthekine
NCT06066138
NCT06898450
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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