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Recruiting
NCT05098132
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
Conditions: Advanced Solid Tumor, Non Small Cell Lung Cancer, Untreated Advanced NSCLC, 1st Line NSCLC
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 364
Sponsor: Synthekine
Location: University of Arizona Cancer Center Tucson Arizona
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.
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 \
Source: ClinicalTrials.gov (NCT05098132). StuddyBuddy aggregates publicly available trial information.
