Clinical Trial Details
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Phase IInterventional
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
Protocol: STUDY00005439NCT: NCT05098132
Overview
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
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
Selected Inclusion Criteria:
- 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.
Selected Exclusion Criteria:
- 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
Investigators
Locations
Emory University Hospital Midtown
Winship Cancer Institute