RECRUITING

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

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 phase 1/2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative, non-squamous, non-small cell lung cancer.

Official Title

A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects With Front-line Advanced NSCLC and Other Selected Indications

Quick Facts

Study Start:2022-01-25
Study Completion:2029-01
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. Phase 1 \[closed to enrollment\]
  2. 2. Phase 2 \[open to enrollment\]:
  3. * Diagnosis of non-small cell lung cancer (NSCLC).
  4. * Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment.
  5. * Non-squamous (NSQ) cell histology.
  6. * No prior systemic therapy for advanced/metastatic NSQ NSCLC.
  7. * Tumor is PD-L1 negative (TPS \<1%) by local testing.
  8. * No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy.
  1. 1. Phase 1 \[closed to enrollment\]
  2. 2. Phase 2 \[open to enrollment\]:
  3. * Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment
  4. * Tumor with small cell, neuroendocrine, or sarcomatoid components.
  5. * Received radiotherapy ≤ 7 days of the first dose of study treatment.
  6. * Known untreated central nervous system metastases
  7. * Any history of carcinomatous meningitis

Contacts and Locations

Study Contact

Synthekine STK-012-101 Contact
CONTACT
650-606-6319
STK-012-101.contact@synthekine.com

Study Locations (Sites)

University of Arizona Cancer Center
Tucson, Arizona, 85721
United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211
United States
Providence Medical Foundation
Fullerton, California, 92835
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
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
Georgetown University
Washington D.C., District of Columbia, 20057
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
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101
United States
Northwell Health
Lake Success, New York, 11042
United States
NYU Langone Health
New York, New York, 10016
United States
Columbia University Irving Medical Center
New York, New York, 10032
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
Baptist Memorial Hospital Cancer Center
Memphis, Tennessee, 38120
United States
Sarah Cannon Research Institute - Nashville
Nashville, Tennessee, 37203
United States
Renovatio Clinical
El Paso, Texas, 79915
United States
Oncology Consultants
Houston, Texas, 77303
United States
Renovatio Clinical
The Woodlands, Texas, 77380
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States
Northwest Medical Specialties
Tacoma, Washington, 98405
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 Date2029-01

Study Record Updates

Study Start Date2022-01-25
Study Completion Date2029-01

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • Non Small Cell Lung Cancer
  • Untreated Advanced NSCLC
  • 1st Line NSCLC