Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Subjects With Solid Tumors
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- STATUS
- Recruiting
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- End date
- Mar 17, 2026
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- participants needed
- 135
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- sponsor
- Synthekine
Summary
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.
Description
The phase 1a portion of the study will evaluate STK-012 monotherapy administered subcutaneously weekly alone and in combination with pembrolizumab administered every 3 weeks intravenously in a standard 3+3 dose-escalation study design. Patients with selected solid tumor types will be enrolled who have progressed after standard of care treatments. The phase 1b dose expansion will evaluate STK-012 at the recommended phase 2 dose in combination with pembrolizumab in selected solid tumor types.
Details
| Condition | Advanced Solid Tumor, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Malignant Melanoma, Renal Cell Carcinoma, Ovarian Cancer, Cervical Cancer, Microsatellite Instability High |
|---|---|
| Treatment | Pembrolizumab, STK-012 |
| Clinical Study Identifier | NCT05098132 |
| Sponsor | Synthekine |
| Last Modified on | 17 May 2022 |
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