Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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.
EXCLUSION CRITERIA
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Advanced Solid Tumor,Non Small Cell Lung Cancer,Untreated Advanced NSCLC,1st Line NSCLC
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
364
Est. Completion Date
Jan 31, 2029
Treatment Type
INTERVENTIONAL
Sponsor
Synthekine
ClinicalTrials.gov NCT Identifier
NCT05098132
Study Number
STK-012-101
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