Mass General - Division of Clinical Research

STK-012 Monotherapy and in Combination Therapy 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 therapy 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

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. 2. Participants enrolled to STK-012 + pembrolizumab combination dose expansion must have selected tumor types and may not have received treatment for metastatic disease. 3. 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. 4. 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. 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. 4. Participants with NSCLC may not have any known actionable genetic aberrations with approved therapies.

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.	Drug: STK-012 pegylated alpha/beta-biased engineered interleukin-2
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.	Drug: STK-012 pegylated alpha/beta-biased engineered interleukin-2
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.	Drug: STK-012 pegylated alpha/beta-biased engineered interleukin-2 Drug: pembrolizumab anti-PD-1 humanized monoclonal antibody
Experimental Part D: STK-012 Q3W monotherapy and STK-012 Q3W + pembrolizumab 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.	Drug: STK-012 pegylated alpha/beta-biased engineered interleukin-2 Drug: pembrolizumab anti-PD-1 humanized monoclonal antibody
Experimental Part E: STK-012 Q3W + pembrolizumab, pemetrexed and carboplatin dose escalation	STK-012 will be administered in sequential ascending doses SC Q3W in combination with pembrolizumab IV Q3W, pemetrexed IV Q3W and carboplatin IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.	Drug: STK-012 pegylated alpha/beta-biased engineered interleukin-2 Drug: pembrolizumab anti-PD-1 humanized monoclonal antibody Drug: pemetrexed antifolate chemotherapy Drug: carboplatin platinum chemotherapy
Experimental Part F: STK-012 Q3W + pembrolizumab, pemetrexed and carboplatin dose expansion	STK-012 will be administered at the RP2D SC in combination with pembrolizumab IV Q3W, pemetrexed IV Q3W and carboplatin IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.	Drug: STK-012 pegylated alpha/beta-biased engineered interleukin-2 Drug: pembrolizumab anti-PD-1 humanized monoclonal antibody Drug: pemetrexed antifolate chemotherapy Drug: carboplatin platinum chemotherapy

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

Contact:
Ryan Sullivan, MD
617-724-4000
rsullivan7@mgh.harvard.edu

More Details

Status: Recruiting
Sponsor: Synthekine

Study Contact

Clinical Operations
650-271-9888
clinicaltrialinfo@synthekine.com

Detailed Description

The phase 1a portion of the study is a dose escalation design to evaluate STK-012 as monotherapy and in combination therapy in patients with selected solid tumors. The phase 1b portion of the study includes dose expansions to evaluate STK-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.