Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors
Purpose
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.
Conditions
- 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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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. 2. Patients must be amenable to a fresh tissue biopsy, unless medically contraindicated. 3. Patients with central nervous system (CNS) metastases must have been treated and be asymptomatic. 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. 2. Received radiotherapy within 2 weeks of the first dose of study treatment. 3. Received prior IL-2-based or IL-15-based cytokine therapy.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Part A: STK-012 weekly (QW) monotherapy dose escalation |
STK-012 will be administered in sequential ascending doses as monotherapy subcutaneously (SC) QW until unacceptable toxicity, disease progression, or withdrawal of consent. |
|
Experimental Part B: STK-012 every three weeks (Q3W) monotherapy dose escalation |
STK-012 will be administered in sequential ascending doses as monotherapy SC Q3W until unacceptable toxicity, disease progression, or withdrawal of consent. |
|
Experimental Part C: STK-012 Q3W + pembrolizumab dose escalation |
STK-012 will be administered in sequential ascending doses SC Q3W in combination with a fixed dose of pembrolizumab intravenously (IV) Q3W until unacceptable toxicity, disease progression, or withdrawal of consent. |
|
Experimental Part D: Dose expansions |
STK-012 will be administered at the RP2D SC as monotherapy and in combination with a fixed dose of pembrolizumab IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent. |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Synthekine
Detailed Description
The phase 1a portion of the study is standard 3+3 dose escalation design to evaluate STK-012 as monotherapy and in combination with pembrolizumab in patients with selected solid tumors who have progressed after standard of care treatments. The phase 1b portion of the study includes dose expansions to evaluate STK-012 as monotherapy and in combination with pembrolizumab at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.