STK-012 Monotherapy and in Combination Therapy in Patients With Solid Tumors
Trial Status: active
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.
Inclusion Criteria
- 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. Selected
Exclusion Criteria
- Received systemic anti-cancer therapy within 3 weeks of the first dose of study treatment or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
- Received radiotherapy within 2 weeks of the first dose of study treatment.
- Received prior IL-2-based or IL-15-based cytokine therapy.
- Participants with NSCLC may not have any known actionable genetic aberrations with approved therapies.
Additional locations may be listed on ClinicalTrials.gov for NCT05098132.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - Tucson
Status: Active
Name Not AvailableCalifornia
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Tina Tieu
Phone: 310-633-8400
Email: TinaTieu@mednet.ucla.edu
Connecticut
New Haven
Yale University
Status: Active
Name Not AvailableDistrict of Columbia
Washington
MedStar Georgetown University Hospital
Status: Active
Name Not AvailableGeorgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not AvailableMassachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not AvailableBrigham and Women's Hospital
Status: Active
Name Not AvailableBeth Israel Deaconess Medical Center
Status: Active
Name Not AvailableMassachusetts General Hospital Cancer Center
Status: Active
Name Not AvailableNew York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Contact: Nurse Navigator
Phone: 212-342-5162
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not AvailableMemorial Sloan Kettering Cancer Center
Status: Active
Name Not AvailableNorth Carolina
Durham
Duke University Medical Center
Status: Active
Name Not AvailableOhio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not AvailablePennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not AvailableThe phase 1a portion of the study is a dose escalation design to evaluate STK-012 as
monotherapy and in combination therapy in patients with selected solid tumors. The phase
1b portion of the study includes dose expansions to evaluate STK-012 as monotherapy and
in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid
tumor types.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationSynthekine
- Primary IDSTK-012-101
- Secondary IDsNCI-2022-00633
- ClinicalTrials.gov IDNCT05098132