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Trial NCT05098132

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

Phase
Phase 1/2
Sponsor
Synthekine
Conditions
Advanced Solid Tumor; Non Small Cell Lung Cancer; Untreated Advanced NSCLC; 1st Line NSCLC
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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 metastasesBrain metastases * Any history of carcinomatous meningitis

Restrictions found (1)

Recruiting in Massachusetts

  • Massachusetts General Hospital · Boston, Suffolk County
  • Beth Israel Deaconess Medical Center · Boston, Suffolk County
  • Dana-Farber Cancer Institute · Boston, Suffolk County