Recruiting
Phase 1
Phase 2

STK-012

Sponsor:

Synthekine

Code:

NCT05098132

Conditions

Advanced Solid Tumor

Non Small Cell Lung Cancer

Untreated Advanced NSCLC

1st Line NSCLC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STK-012

pembrolizumab KEYTRUDA®

pemetrexed

carboplatin

Study Details

Brief 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 or STK11 mutated, non-squamous, non-small cell lung cancer.

Conditions

Advanced Solid Tumor

Non Small Cell Lung Cancer

Untreated Advanced NSCLC

1st Line NSCLC

Study ID

NCT05098132

Start date

Jan 25, 2022

Status verified date

Jun, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

364 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a: STK-012 monotherapy dose escalation

STK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications

experimental: Phase 1a: STK-012 + pembrolizumab dose escalation

STK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications

experimental: Phase 1a: STK-012 + standard of care (SoC) dose escalation

STK-012 SC + SoC IV in first-line non-squamous (NSQ) NSCLC

experimental: Phase 1b: STK-012 monotherapy expansion

STK-012 SC monotherapy in selected solid tumor indications

experimental: Phase 1b: STK-012 + pembrolizumab dose expansion

STK-012 SC will be administered in combination with pembrolizumab IV in selected solid tumor indications

experimental: Phase 1b: STK-012 + SoC dose expansion

STK-012 SC + SoC IV in first-line PD-L1 negative NSQ NSCLC

experimental: Phase 2: Arm A

STK-012 2.25 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC

experimental: Phase 2: Arm B

STK-012 1.5 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC

active comparator: Phase 2: Arm C

SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC

Interventions

STK-012

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

pembrolizumab KEYTRUDA®

anti-PD-1 monoclonal antibody

pemetrexed

chemotherapy

carboplatin

chemotherapy

Primary outcome measure

  • Phase 1a: Treatment emergent adverse events (TEAEs) [ Time Frame: From 1st dose of study treatment through 90 days after last dose ]
  • Phase 1a: Serious adverse events (SAEs) [ Time Frame: From 1st dose of study treatment through 90 days after last dose ]
  • Phase 1a: Dose limiting toxicities (DLTs) [ Time Frame: Cycle 1, Days 1 through 21 ]
  • Phase 1a: Deaths [ Time Frame: From 1st dose of study treatment until death, up to 4 years ]
  • Phase 1b: TEAEs at the RP2D [ Time Frame: From 1st dose of study treatment through 90 days after last dose ]
  • Phase 1b: SAEs at the RP2D [ Time Frame: From 1st dose of study treatment through 90 days after last dose ]
  • Phase 1b: Deaths at the RP2D [ Time Frame: From 1st dose of study treatment until death, up to 4 years ]
  • Phase 2: Overall response rate (ORR) in Arm A versus Arm C [ Time Frame: From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years ]

Central Contacts and Locations

Central contacts

Synthekine STK-012-101 Contact

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

Locations

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85721

Beverly Hills Cancer Center

Recruiting

Beverly Hills, California, United States, 90211

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Cedars Sinai

Recruiting

Los Angeles, California, United States, 90048

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

UCLA Hematology/Oncology - Santa Monica

Recruiting

Santa Monica, California, United States, 90404

Yale New Haven Hospital, Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Georgetown University

Recruiting

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

Winship Cancer Institute, Emory University

Recruiting

Atlanta, Georgia, United States, 30322

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

HealthPartners Cancer Center at Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Northwell Health

Recruiting

Lake Success, New York, United States, 11042

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

University Hospitals Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

The James Cancer Hospital and Solove Research Institute

Recruiting

Columbus, Ohio, United States, 43210

Providence Cancer Institute

Recruiting

Portland, Oregon, United States, 97123

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Oncology Consultants

Recruiting

Houston, Texas, United States, 77303

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Synthekine

Last update posted

Jul 21, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Synthekine on 2026-07-21.