STK-012 Monotherapy and in Combination Therapy in Patients with Solid Tumors

Description

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

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Study Overview

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Study Details

Study overview

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.

A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 As a Single Agent and in Combination Therapy in Patients with Selected Advanced Solid Tumors

STK-012 Monotherapy and in Combination Therapy in Patients with Solid Tumors

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

La Jolla

UC San Diego Moores Cancer Center, La Jolla, California, United States, 92093-0698

Santa Monica

UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States, 90404

New Haven

Yale New Haven Hospital, Yale Cancer Center, New Haven, Connecticut, United States, 06510

Atlanta

Winship Cancer Institute, Emory University, Atlanta, Georgia, United States, 30322

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Lake Success

Northwell Health, Lake Success, New York, United States, 11042

New York City

Columbia University Irving Medical Center, New York City, New York, United States, 10032

New York

NYU Langone Health, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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.
  • 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.
  • 4. Participants with NSCLC may not have any known actionable genetic aberrations with approved therapies.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Synthekine,

Study Record Dates

2027-10