Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
Sponsor: Synthekine
ClinicalTrials ID:NCT05098132
This phase 1/2 study evaluates STK-012, an engineered IL-2, alone and with pembrolizumab, pemetrexed, and carboplatin. Phase 1 (closed) focused on dose escalation/expansion in solid tumors. Phase 2 (open) targets PD-L1 negative, non-squamous NSCLC patients, comparing STK-012 combinations to standard care. Eligibility excludes prior systemic therapy and actionable genomic aberrations.
Patient Parameters
| Parameter | Options |
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Program 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.
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 patients with first line, PD-L1 negative, non-squamous, non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria
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Phase 1 [closed to enrollment]
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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
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Phase 1 [closed to enrollment]
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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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Arizona Cancer Center | 85721 | Tucson | Arizona |
| Beverly Hills Cancer Center | 90211 | Beverly Hills | California |
| Providence Medical Foundation | 92835 | Fullerton | California |
| UC San Diego Moores Cancer Center | 92093-0698 | La Jolla | California |
| Hoag Memorial Hospital Presbyterian | 92663 | Newport Beach | California |
| UCLA Hematology/Oncology - Santa Monica | 90404 | Santa Monica | California |
| Yale New Haven Hospital, Yale Cancer Center | 06510 | New Haven | Connecticut |
| Georgetown University | 20057 | Washington D.C. | District of Columbia |
| Winship Cancer Institute, Emory University | 30322 | Atlanta | Georgia |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
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