RecruitingRecruiting
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
NCT05098132 · Synthekine
In plain English
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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
About this study
Phase 1: The phase 1a portion is a dose escalation study to evaluate STK-012 as monotherapy and in combination therapy in patients with selected solid tumors. The phase 1b portion is a dose expansion study to evaluate STK-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.
Phase 2: The phase 2 portion is a randomized, open label study to evaluate STK-012 at two dose levels in combination with standard of care (SoC) pembrolizumab, pemetrexed and carboplatin, versus SoC, in patients with first line, PD-L1 negative or STK11 mutated, non-squamous, non-small cell lung cancer. Subjects in the randomized Phase 2 portion (Part G) will be randomized 1:1:1 and stratified by tumor PD-L1 expression and STK11 mutation status.
Eligibility criteria
Selected Inclusion Criteria:
1. Phase 1: Selected advanced solid tumors
2. Phase 2:
* Diagnosis of non-small cell lung cancer (NSCLC).
* Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment.
* Non-squamous (NSQ) cell histology.
* No prior systemic therapy for advanced/metastatic NSQ NSCLC.
* Must have a tumor that meets at least one of the following criteria on local testing:
* PD-L1 negative (TPS \<1%), OR;
* STK11 mutated on tumor tissue or ctDNA
* 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.
Selected Exclusion Criteria:
2\. Phase 2:
* Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment
* Rare tumor subtypes (mucinous histology or tumors with small cell, neuroendocrine, or sarcomatoid components).
* Received radiotherapy ≤ 7 days of the first dose of study treatment.
* Known active central nervous system metastases
* Any history of carcinomatous meningitis
Study design
Enrollment target: 364 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-01-25
Estimated completion: 2029-01
Last updated: 2026-07-21
Interventions
Drug: STK-012Drug: pembrolizumab KEYTRUDA®Drug: pemetrexedDrug: carboplatin
Primary outcomes
- • Phase 1a: Treatment emergent adverse events (TEAEs) (From 1st dose of study treatment through 90 days after last dose)
- • Phase 1a: Serious adverse events (SAEs) (From 1st dose of study treatment through 90 days after last dose)
- • Phase 1a: Dose limiting toxicities (DLTs) (Cycle 1, Days 1 through 21)
Sponsor
Synthekine · industry
With: Merck Sharp & Dohme LLC
Contacts & investigators
ContactSynthekine STK-012-101 Contact · contact · STK-012-101.contact@synthekine.com · 650-606-6319
All locations (47)
University of Arizona Cancer CenterRecruiting
Tucson, Arizona, United States
Beverly Hills Cancer CenterRecruiting
Beverly Hills, California, United States
Providence Medical FoundationRecruiting
Fullerton, California, United States
UC San Diego Moores Cancer CenterActive Not Recruiting
La Jolla, California, United States
Cedars SinaiRecruiting
Los Angeles, California, United States
Hoag Memorial Hospital PresbyterianRecruiting
Newport Beach, California, United States
UCLA Hematology/Oncology - Santa MonicaRecruiting
Santa Monica, California, United States
Yale New Haven Hospital, Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Georgetown UniversityRecruiting
Washington D.C., District of Columbia, United States
Winship Cancer Institute, Emory UniversityRecruiting
Atlanta, Georgia, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
University of MarylandRecruiting
Baltimore, Maryland, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
HealthPartners Cancer Center at Regions HospitalRecruiting
Saint Paul, Minnesota, United States
Northwell HealthRecruiting
Lake Success, New York, United States
NYU Langone HealthRecruiting
New York, New York, United States
Columbia University Irving Medical CenterActive Not Recruiting
New York, New York, United States
Memorial Sloan-Kettering Cancer CenterRecruiting
New York, New York, United States
Duke Cancer CenterActive Not Recruiting
Durham, North Carolina, United States
University Hospitals ClevelandRecruiting
Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research InstituteRecruiting
Columbus, Ohio, United States
Providence Cancer InstituteRecruiting
Portland, Oregon, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer CenterTerminated
Pittsburgh, Pennsylvania, United States
Baptist Memorial Hospital Cancer CenterActive Not Recruiting
Memphis, Tennessee, United States
Sarah Cannon Research Institute - NashvilleActive Not Recruiting
Nashville, Tennessee, United States
Renovatio ClinicalWithdrawn
El Paso, Texas, United States
Oncology ConsultantsRecruiting
Houston, Texas, United States
Renovatio ClinicalWithdrawn
The Woodlands, Texas, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States
Northwest Medical SpecialtiesActive Not Recruiting
Tacoma, Washington, United States
LTD High Technology Hospital MedcenterRecruiting
Batumi, Georgia
Caraps Medline, Ltd (JSC VIAN)Recruiting
Tbilisi, Georgia
Institute of Clinical Oncology (ICO)Recruiting
Tbilisi, Georgia
Israel Georgian Medical Research Clinic HealthycoreRecruiting
Tbilisi, Georgia
START DublinRecruiting
Dublin, Ireland
St. James HospitalRecruiting
Dublin, Ireland
Beaumont HospitalRecruiting
Dublin, Ireland
University Hospital GalwayRecruiting
Galway, Ireland
Hospital Quirón BarcelonaRecruiting
Barcelona, Spain
START RiojaRecruiting
Logroño, Spain
MD AndersonRecruiting
Madrid, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Hospital Regional de MálagaRecruiting
Málaga, Spain
Clinica Universidad de Navarra - PamplonaRecruiting
Pamplona, Spain