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

RecruitingPhase 1, Phase 2

Sponsor: Synthekine

Conditions: Advanced Solid Tumor, Non Small Cell Lung Cancer, Untreated Advanced NSCLC, 1st Line NSCLC

Interventions: STK-012, pembrolizumab KEYTRUDA®, pemetrexed, carboplatin

Countries: United States, Georgia, Ireland, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (47)

Tucson, Arizona, United States
Beverly Hills, California, United States
Fullerton, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Santa Monica, California, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Saint Paul, Minnesota, United States
Lake Success, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
El Paso, Texas, United States
Houston, Texas, United States
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