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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05098132
Other study ID # STK-012-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 25, 2022
Est. completion date October 2025

Study information

Verified date November 2023
Source Synthekine
Contact Clinical Operations
Phone 650-271-9888
Email clinicaltrialinfo@synthekine.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 202
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Selected 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


Intervention

Drug:
STK-012
pegylated alpha/beta-biased engineered interleukin-2
Pembrolizumab
anti-PD-1 humanized monoclonal antibody

Locations

Country Name City State
United States Winship Cancer Institute, Emory University Atlanta Georgia
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Duke Cancer Center Durham North Carolina
United States NEXT Virginia Fairfax Virginia
United States UC San Diego Moores Cancer Center La Jolla California
United States Sarah Cannon Research Institute - Nashville Nashville Tennessee
United States Yale New Haven Hospital, Yale Cancer Center New Haven Connecticut
United States Columbia University Irving Medical Center New York New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States UPMC Hillman Cancer Center Pittsburgh Pennsylvania
United States UCLA Hematology/Oncology - Santa Monica Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
Synthekine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose limiting toxicities (DLTs) Incidence of adverse events (AEs) meeting protocol defined DLT criteria and determination of the maximum tolerated dose (MTD) and/or the RP2D of STK-012 as a single agent and in combination with pembrolizumab 1 cycle (21 days)
Primary Adverse events Assess the safety and tolerability of STK-012 as monotherapy and in combination with pembrolizumab by review of AEs including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events leading to treatment discontinuation, and adverse events resulting in death. From 1st dose of STK-012 through 90 days after last dose of STK-012
Secondary Objective response rate (ORR) The ORR is defined as the proportion of patients with confirmed CR or confirmed PR, based on RECIST Version 1.1 after STK-012 administration as monotherapy and in combination with pembrolizumab Up to 24 months
Secondary Progression-free survival (PFS) PFS is defined as the time from the start of treatment with STK-012 until the first documentation of disease progression or death due to any cause, whichever occurs first after STK-012 administration as monotherapy and in combination with pembrolizumab Up to 24 months
Secondary Overall Survival (OS) Overall survival is defined as the time from the start of treatment with STK-012 until death due to any cause after STK-012 administration as monotherapy and in combination with pembrolizumab Up to 24 months
Secondary Area under the curve (AUC) of STK-012 The AUC of STK-012 will be measured at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab From 1st dose of STK-012 through 30 days after last dose of STK-012
Secondary Maximum concentration (Cmax) of STK-012 The Cmax of STK-012 will be measured at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab From 1st dose of STK-012 through 30 days after last dose of STK-012
Secondary Time of maximum concentration (Tmax) of STK-012 The Tmax of STK-012 will be measured at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab From 1st dose of STK-012 through 30 days after last dose of STK-012
Secondary Half-life (T1/2) of STK-012 The T1/2 of STK-012 will be measured at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab From 1st dose of STK-012 through 30 days after last dose of STK-012
Secondary Immunogenicity The immunogenicity of STK-012 will be assessed by summarizing the number of patients who develop detectable anti-drug antibodies (ADAs) at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab From 1st dose of STK-012 through 30 days after last dose of STK-012
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