Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
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
364 participants
Jan 25, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- Phase 1 \[closed to enrollment\]
- 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.
Exclusion Criteria7
- Phase 1 \[closed to enrollment\]
- Phase 2 \[open to enrollment\]:
- Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment
- Tumor with small cell, neuroendocrine, or sarcomatoid components.
- Received radiotherapy ≤ 7 days of the first dose of study treatment.
- Known untreated central nervous system metastases
- Any history of carcinomatous meningitis
Interventions
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
anti-PD-1 monoclonal antibody
chemotherapy
chemotherapy
Locations(27)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05098132