RecruitingPhase 1Phase 2NCT05098132

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

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


Sponsor

Synthekine

Enrollment

364 participants

Start Date

Jan 25, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called STK-012, alone or combined with other treatments, for people with advanced non-small cell lung cancer (NSCLC) whose tumor does not respond to a protein called PD-L1. **You may be eligible if...** - You have been diagnosed with advanced or metastatic non-squamous non-small cell lung cancer (Stage IIIB, IIIC, or IV) - Your tumor tests negative for PD-L1 - You have not yet received any systemic treatment for your advanced lung cancer - Your cancer does not have specific gene mutations (like EGFR, ALK, or ROS1) that have their own targeted treatments - You have measurable disease that can be tracked on scans **You may NOT be eligible if...** - You have previously received immunotherapy drugs (like anti-PD-1 or anti-CTLA-4) - Your tumor has small cell, neuroendocrine, or sarcomatoid features - You have active brain metastases causing symptoms - You have serious uncontrolled health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSTK-012

Engineered Interleukin-2 (IL-2) selective for antigen activated T cells

DRUGpembrolizumab

anti-PD-1 monoclonal antibody

DRUGpemetrexed

chemotherapy

DRUGcarboplatin

chemotherapy


Locations(27)

University of Arizona Cancer Center

Tucson, Arizona, United States

Beverly Hills Cancer Center

Beverly Hills, California, United States

Providence Medical Foundation

Fullerton, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, United States

Yale New Haven Hospital, Yale Cancer Center

New Haven, Connecticut, United States

Georgetown University

Washington D.C., District of Columbia, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

HealthPartners Cancer Center at Regions Hospital

Saint Paul, Minnesota, United States

Northwell Health

Lake Success, New York, United States

NYU Langone Health

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Duke Cancer Center

Durham, North Carolina, United States

The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Baptist Memorial Hospital Cancer Center

Memphis, Tennessee, United States

Sarah Cannon Research Institute - Nashville

Nashville, Tennessee, United States

Renovatio Clinical

El Paso, Texas, United States

Oncology Consultants

Houston, Texas, United States

Renovatio Clinical

The Woodlands, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

Northwest Medical Specialties

Tacoma, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05098132


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