Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05098132

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

Led by Synthekine · Updated on 2026-03-18

364

Participants Needed

27

Research Sites

361 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of non-small cell lung cancer (NSCLC)
  • Stage IV or Stage IIIB/IIIC NSCLC and not a candidate for definitive treatment
  • Non-squamous cell histology
  • No prior systemic therapy for advanced/metastatic non-squamous NSCLC
  • Tumor is PD-L1 negative (TPS <1%) by local testing
  • No known actionable EGFR, ALK, ROS1, or other genomic aberrations with available standard first-line therapy
Not Eligible

You will not qualify if you...

  • Prior treatment with immune checkpoint inhibitors (anti-PD[L]1 and/or anti-CTLA-4)
  • Tumor contains small cell, neuroendocrine, or sarcomatoid components
  • Received radiotherapy within 7 days before the first dose of study treatment
  • Known untreated central nervous system metastases
  • History of carcinomatous meningitis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 27 locations

1

University of Arizona Cancer Center

Tucson, Arizona, United States, 85721

Actively Recruiting

2

Beverly Hills Cancer Center

Beverly Hills, California, United States, 90211

Actively Recruiting

3

Providence Medical Foundation

Fullerton, California, United States, 92835

Actively Recruiting

4

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093-0698

Active, Not Recruiting

5

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Actively Recruiting

6

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, United States, 90404

Actively Recruiting

7

Yale New Haven Hospital, Yale Cancer Center

New Haven, Connecticut, United States, 06510

Actively Recruiting

8

Georgetown University

Washington D.C., District of Columbia, United States, 20057

Actively Recruiting

9

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

10

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

11

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

12

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

13

HealthPartners Cancer Center at Regions Hospital

Saint Paul, Minnesota, United States, 55101

Actively Recruiting

14

Northwell Health

Lake Success, New York, United States, 11042

Actively Recruiting

15

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

16

Columbia University Irving Medical Center

New York, New York, United States, 10032

Active, Not Recruiting

17

Memorial Sloan-Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

18

Duke Cancer Center

Durham, North Carolina, United States, 27710

Actively Recruiting

19

The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States, 43210

Actively Recruiting

20

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Active, Not Recruiting

21

Baptist Memorial Hospital Cancer Center

Memphis, Tennessee, United States, 38120

Actively Recruiting

22

Sarah Cannon Research Institute - Nashville

Nashville, Tennessee, United States, 37203

Active, Not Recruiting

23

Renovatio Clinical

El Paso, Texas, United States, 79915

Withdrawn

24

Oncology Consultants

Houston, Texas, United States, 77303

Actively Recruiting

25

Renovatio Clinical

The Woodlands, Texas, United States, 77380

Withdrawn

26

NEXT Virginia

Fairfax, Virginia, United States, 22031

Actively Recruiting

27

Northwest Medical Specialties

Tacoma, Washington, United States, 98405

Actively Recruiting

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Research Team

S

Synthekine STK-012-101 Contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

9

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