A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects With Front-line Advanced NSCLC and Other Selected Indications
Synthekine
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, non-squamous, non-small cell lung cancer.
Description
Phase 1 \[closed to enrollment\]: The phase 1a portion is a dose escalation study to evaluate STK-012 as monotherapy and in combination therapy in patients with selected solid tumors. The phase 1b portion is a dose expansion study to evaluate STK-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types. Phase 2 \[open to enrollment\]: The phase 2 portion is a randomized, open label study to evaluate STK-012 at two dose levels in combination with standard of care (SoC) pembrolizumab, pemetrexed and carboplatin, versus SoC, in…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Selected Inclusion Criteria: 1. Phase 1 \[closed to enrollment\] 2. Phase 2 \[open to enrollment\]: * 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. * Tumor is PD-L1 negative (TPS \<1%) by local testing. * 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: 1. Phase 1…
Interventions
- DrugSTK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
- Drugpembrolizumab
anti-PD-1 monoclonal antibody
- Drugpemetrexed
chemotherapy
- Drugcarboplatin
chemotherapy
Locations (27)
- University of Arizona Cancer CenterTucson, Arizona
- Beverly Hills Cancer CenterBeverly Hills, California
- Providence Medical FoundationFullerton, California
- UC San Diego Moores Cancer CenterLa Jolla, California
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- UCLA Hematology/Oncology - Santa MonicaSanta Monica, California