RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-01-25
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05098132

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 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. 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. 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. 2. Received radiotherapy within 2 weeks of the first dose of study treatment.
  3. 3. Received prior IL-2-based or IL-15-based cytokine therapy.
  4. 4. Participants with NSCLC may not have any known actionable genetic aberrations with approved therapies.

Contacts and Locations

Study Contact

Clinical Operations
CONTACT
650-271-9888
clinicaltrialinfo@synthekine.com

Study Locations (Sites)

UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698
United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404
United States
Yale New Haven Hospital, Yale Cancer Center
New Haven, Connecticut, 06510
United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Northwell Health
Lake Success, New York, 11042
United States
Columbia University Irving Medical Center
New York City, New York, 10032
United States
NYU Langone Health
New York, New York, 10016
United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
United States
Duke Cancer Center
Durham, North Carolina, 27710
United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Sarah Cannon Research Institute - Nashville
Nashville, Tennessee, 37203
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Synthekine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-25
Study Completion Date2027-10

Study Record Updates

Study Start Date2022-01-25
Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

  • 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