Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors
About the study
This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of STK-012 as monotherapy and in combination with pembrolizumab in patients with selected advanced solid tumors.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Selected Inclusion Criteria
- Patients must have selected tumor types and must have progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment.
- Patients must be amenable to a fresh tissue biopsy, unless medically contraindicated.
- Patients with central nervous system (CNS) metastases must have been treated and be asymptomatic.
EXCLUSION CRITERIA
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Advanced Solid Tumor,Non Small Cell Lung Cancer,Head and Neck Squamous Cell Carcinoma,Malignant Melanoma,Renal Cell Carcinoma,Cervical Cancer,Microsatellite Instability High,Gastric Cancer,GastroEsophageal Cancer,Urothelial Carcinoma,Mismatch Repair Deficiency
Age (in years)
18+
Phase
Phase 1
Participants needed
202
Est. Completion Date
Oct 31, 2025
Treatment type
Interventional
Sponsor
Synthekine
ClinicalTrials.gov identifier
NCT05098132
Study number
STK-012-101
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