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
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)
- Brain metastasesConditionalexclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County
- Beth Israel Deaconess Medical Center · Boston, Suffolk County
- Dana-Farber Cancer Institute · Boston, Suffolk County