drugset / Trial / NCT05098132

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

NCT05098132

Phase 1/2 Recruiting 364 enrolled Synthekine Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-01-25
Primary completion
2029-01
Completion
2029-01

Drugs

EvaluationDrugModalityDoseRoute
Subject STK-012 Protein / enzyme biologic 1.5 mg Subcutaneous
Subject STK-012 Protein / enzyme biologic 2.25 mg Subcutaneous
Background Carboplatin Small molecule Intravenous
Background Pembrolizumab Monoclonal antibody
Background Pemetrexed Small molecule Intravenous