Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors

Gastric Cancer Clinical Trial

Official title:

A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05098132
• Other study ID #: STK-012-101
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Carcinoma
• Carcinoma, Renal Cell
• Cervical Cancer
• Gastric Cancer
• GastroEsophageal Cancer
• Head and Neck Squamous Cell Carcinoma
• Malignant Melanoma
• Melanoma
• Microsatellite Instability
• Microsatellite Instability High
• Mismatch Repair Deficiency
• Non Small Cell Lung Cancer
• Renal Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Urothelial Carcinoma

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