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

a study on Solid Tumor Lung Cancer Non-Small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma Skin Cancer/Melanoma Kidney Cancer Renal Cell Carcinoma Cervical Cancer Microsatellite Instability Stomach Cancer Esophageal Cancer Transitional Cell Carcinoma Mismatch Repair Deficiency Carcinoma Head and Neck Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

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.

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

Details

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.

Keywords

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, Carcinoma, Melanoma, Squamous Cell Carcinoma of Head and Neck, Microsatellite Instability, Pembrolizumab, STK-012

Eligibility

For people ages 18 years and up

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.

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093-0698 United States
  • UCLA Hematology/Oncology - Santa Monica accepting new patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Synthekine
ID
NCT05098132
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 202 study participants
Last Updated
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