STK-012 Monotherapy and in Combination Therapy 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 therapy 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:
- 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.
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.
- Participants with NSCLC may not have any known actionable genetic aberrations with approved therapies.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study 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
18+
Phase
PHASE1
Participants Needed
202
Est. Completion Date
Oct 31, 2027
Treatment Type
INTERVENTIONAL
Sponsor
Synthekine
ClinicalTrials.gov NCT Identifier
NCT05098132
Study Number
STK-012-101
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