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
Status: Recruiting
Location: See all (47) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 or STK11 mutated, non-squamous, non-small cell lung cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Phase 1: Selected advanced solid tumors
• Phase 2:
‣ 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.
⁃ Must have a tumor that meets at least one of the following criteria on local testing:
• PD-L1 negative (TPS \<1%), OR;
∙ STK11 mutated on tumor tissue or ctDNA
⁃ 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.
Locations
United States
Arizona
University of Arizona Cancer Center
RECRUITING
Tucson
California
Beverly Hills Cancer Center
RECRUITING
Beverly Hills
Providence Medical Foundation
RECRUITING
Fullerton
UC San Diego Moores Cancer Center
ACTIVE_NOT_RECRUITING
La Jolla
Cedars Sinai
RECRUITING
Los Angeles
Hoag Memorial Hospital Presbyterian
RECRUITING
Newport Beach
UCLA Hematology/Oncology - Santa Monica
RECRUITING
Santa Monica
Connecticut
Yale New Haven Hospital, Yale Cancer Center
RECRUITING
New Haven
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Georgia
Winship Cancer Institute, Emory University
RECRUITING
Atlanta
Illinois
University of Chicago
RECRUITING
Chicago
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
University of Maryland
RECRUITING
Baltimore
Minnesota
HealthPartners Cancer Center at Regions Hospital
RECRUITING
Saint Paul
North Carolina
Duke Cancer Center
ACTIVE_NOT_RECRUITING
Durham
New York
Northwell Health
RECRUITING
Lake Success
Columbia University Irving Medical Center
ACTIVE_NOT_RECRUITING
New York
Memorial Sloan-Kettering Cancer Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Ohio
University Hospitals Cleveland
RECRUITING
Cleveland
The James Cancer Hospital and Solove Research Institute
RECRUITING
Columbus
Oregon
Providence Cancer Institute
RECRUITING
Portland
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
UPMC Hillman Cancer Center
TERMINATED
Pittsburgh
Tennessee
Baptist Memorial Hospital Cancer Center
ACTIVE_NOT_RECRUITING
Memphis
Sarah Cannon Research Institute - Nashville
ACTIVE_NOT_RECRUITING
Nashville
Texas
Renovatio Clinical
WITHDRAWN
El Paso
Oncology Consultants
RECRUITING
Houston
Renovatio Clinical
WITHDRAWN
The Woodlands
Virginia
NEXT Virginia
RECRUITING
Fairfax
Washington
Northwest Medical Specialties
ACTIVE_NOT_RECRUITING
Tacoma
Other Locations
Georgia
LTD High Technology Hospital Medcenter
RECRUITING
Batumi
Caraps Medline, Ltd (JSC VIAN)
RECRUITING
Tbilisi
Institute of Clinical Oncology (ICO)
RECRUITING
Tbilisi
Israel Georgian Medical Research Clinic Healthycore
RECRUITING
Tbilisi
Ireland
Beaumont Hospital
RECRUITING
Dublin
St. James Hospital
RECRUITING
Dublin
START Dublin
RECRUITING
Dublin
University Hospital Galway
RECRUITING
Galway
Spain
Hospital Quirón Barcelona
RECRUITING
Barcelona
START Rioja
RECRUITING
Logroño
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
MD Anderson
RECRUITING
Madrid
Hospital Regional de Málaga
RECRUITING
Málaga
Clinica Universidad de Navarra - Pamplona
RECRUITING
Pamplona
Contact Information
Primary
Synthekine STK-012-101 Contact
STK-012-101.contact@synthekine.com
650-606-6319
Time Frame
Start Date: 2022-01-25
Estimated Completion Date: 2029-01
Participants
Target number of participants: 364
Treatments
Experimental: Phase 1a: STK-012 monotherapy dose escalation
STK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications
Experimental: Phase 1a: STK-012 + pembrolizumab dose escalation
STK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications
Experimental: Phase 1a: STK-012 + standard of care (SoC) dose escalation
STK-012 SC + SoC IV in first-line non-squamous (NSQ) NSCLC
Experimental: Phase 1b: STK-012 monotherapy expansion
STK-012 SC monotherapy in selected solid tumor indications
Experimental: Phase 1b: STK-012 + pembrolizumab dose expansion
STK-012 SC will be administered in combination with pembrolizumab IV in selected solid tumor indications
Experimental: Phase 1b: STK-012 + SoC dose expansion
STK-012 SC + SoC IV in first-line PD-L1 negative NSQ NSCLC
Experimental: Phase 2: Arm A
STK-012 2.25 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC
Experimental: Phase 2: Arm B
STK-012 1.5 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC
Active_comparator: Phase 2: Arm C
SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Synthekine