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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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

  1. 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

ArmDescriptionAssigned 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: 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

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.