A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 as a Single Agent and in Combination Therapy in Patients With Selected Advanced Solid Tumors
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants enrolled to STK-012 monotherapy dose escalation and expansion and STK-012 + pembrolizumab combination dose escalation must have selected tumor types and progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment.
• Participants enrolled to STK-012 + pembrolizumab combination dose expansion must have selected tumor types and may not have received treatment for metastatic disease.
• Participants enrolled to STK-012 dose escalation combination treatment with pembrolizumab, pemetrexed and carboplatin must have NSCLC and may not have received treatment for metastatic disease.
• Participants enrolled to STK-012 dose expansion combination treatment with pembrolizumab, pemetrexed and carboplatin must have PD-L1 negative NSCLC and may not have received treatment for metastatic disease.
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
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
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Minnesota
HealthPartners Cancer Center at Regions Hospital
RECRUITING
Saint Paul
North Carolina
Duke Cancer Center
RECRUITING
Durham
New York
Northwell Health
RECRUITING
Lake Success
Columbia University Irving Medical Center
RECRUITING
New York
Memorial Sloan-Kettering Cancer Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Ohio
The James Cancer Hospital and Solove Research Institute
RECRUITING
Columbus
Pennsylvania
UPMC Hillman Cancer Center
ACTIVE_NOT_RECRUITING
Pittsburgh
Tennessee
Baptist Memorial Hospital Cancer Center
RECRUITING
Memphis
Sarah Cannon Research Institute - Nashville
RECRUITING
Nashville
Texas
Renovatio Clinical
RECRUITING
El Paso
Oncology Consultants
RECRUITING
Houston
Renovatio Clinical
RECRUITING
The Woodlands
Virginia
NEXT Virginia
RECRUITING
Fairfax
Washington
Northwest Medical Specialties
RECRUITING
Tacoma
Contact Information
Primary
Clinical Operations
clinicaltrialinfo@synthekine.com
650-271-9888
Time Frame
Start Date:2022-01-25
Estimated Completion Date:2027-10
Participants
Target number of participants:202
Treatments
Experimental: Part A: STK-012 weekly (QW) monotherapy dose escalation
STK-012 will be administered in sequential ascending doses as monotherapy subcutaneously (SC) QW until unacceptable toxicity, disease progression, or withdrawal of consent.
Experimental: Part B: STK-012 every three weeks (Q3W) monotherapy dose escalation
STK-012 will be administered in sequential ascending doses as monotherapy SC Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.
Experimental: Part C: STK-012 Q3W + pembrolizumab dose escalation
STK-012 will be administered in sequential ascending doses SC Q3W in combination with a fixed dose of pembrolizumab intravenously (IV) Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.
Experimental: Part D: STK-012 Q3W monotherapy and STK-012 Q3W + pembrolizumab dose expansions
STK-012 will be administered at the RP2D SC as monotherapy and in combination with a fixed dose of pembrolizumab IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.
Experimental: Part E: STK-012 Q3W + pembrolizumab, pemetrexed and carboplatin dose escalation
STK-012 will be administered in sequential ascending doses SC Q3W in combination with pembrolizumab IV Q3W, pemetrexed IV Q3W and carboplatin IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.
Experimental: Part F: STK-012 Q3W + pembrolizumab, pemetrexed and carboplatin dose expansion
STK-012 will be administered at the RP2D SC in combination with pembrolizumab IV Q3W, pemetrexed IV Q3W and carboplatin IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.