NCT05098132 · Synthekine
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
(SYNERGY-101)
What this study is about
This is a phase 1/2, conducted at multiple hospitals, where both patients and doctors know the treatment given study. The phase 1 portion is a gradually increasing doses and expansion study of STK-012 as treatment given alone and in two or more treatments used together in patients with selected advanced solid tumors.
View original scientific 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 or STK11 mutated, non-squamous, non-small cell lung cancer.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Phase 1: Selected advanced solid tumors
- 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
Where
- Tucson, Arizona
- Beverly Hills, California
- Fullerton, California
- La Jolla, California
- Los Angeles, California
- Newport Beach, California
- Santa Monica, California
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Atlanta, Georgia
- Chicago, Illinois
- Baltimore, Maryland
And 17 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations