Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
Recruiting · NCT05098132 · Interventional (participants receive a specific treatment) · Lead sponsor: Synthekine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Selected
Exclusion criteria
- \. Phase 2:
- Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment
- Rare tumor subtypes (mucinous histology or tumors with small cell, neuroendocrine, or sarcomatoid components).
- Received radiotherapy ≤ 7 days of the first dose of study treatment.
- Known active central nervous system metastases
- Any history of carcinomatous meningitis
Where it is running
47 locations listed across 18 US states.
- 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
- Cedars Sinai - Los Angeles, 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
- University of Chicago - Chicago, Illinois, United States
- University of Maryland - Baltimore, Maryland, 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
- University Hospitals Cleveland - Cleveland, Ohio, United States
- The James Cancer Hospital and Solove Research Institute - Columbus, Ohio, United States
- Providence Cancer Institute - Portland, Oregon, United States
- Fox Chase Cancer Center - Philadelphia, Pennsylvania, 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
- Hospital Quirón Barcelona - Barcelona, Spain
- LTD High Technology Hospital Medcenter - Batumi, Georgia
- START Dublin - Dublin, Ireland
- St. James Hospital - Dublin, Ireland
- Beaumont Hospital - Dublin, Ireland
- University Hospital Galway - Galway, Ireland
- START Rioja - Logroño, Spain
- MD Anderson - Madrid, Spain
- Hospital Universitario Ramon y Cajal - Madrid, Spain
- Hospital Regional de Málaga - Málaga, Spain
- Clinica Universidad de Navarra - Pamplona - Pamplona, Spain
- Caraps Medline, Ltd (JSC VIAN) - Tbilisi, Georgia
- Institute of Clinical Oncology (ICO) - Tbilisi, Georgia
- Israel Georgian Medical Research Clinic Healthycore - Tbilisi, Georgia