Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
Purpose
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.
Conditions
- Advanced Solid Tumor
- Non Small Cell Lung Cancer
- Untreated Advanced NSCLC
- 1st Line NSCLC
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- Phase 1 [closed to enrollment] 2. 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 Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1a: STK-012 monotherapy dose escalation |
STK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications |
|
|
Experimental Phase 1a: STK-012 + pembrolizumab dose escalation |
STK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications |
|
|
Experimental Phase 1a: STK-012 + standard of care (SoC) dose escalation |
STK-012 SC + SoC IV in first-line non-squamous (NSQ) NSCLC |
|
|
Experimental Phase 1b: STK-012 monotherapy expansion |
STK-012 SC monotherapy in selected solid tumor indications |
|
|
Experimental Phase 1b: STK-012 + pembrolizumab dose expansion |
STK-012 SC will be administered in combination with pembrolizumab IV in selected solid tumor indications |
|
|
Experimental Phase 1b: STK-012 + SoC dose expansion |
STK-012 SC + SoC IV in first-line PD-L1 negative NSQ NSCLC |
|
|
Experimental Phase 2: Arm A |
STK-012 2.25 mg SC Q3W + SoC IV in first-line PD-L1 negative NSQ NSCLC |
|
|
Experimental Phase 2: Arm B |
STK-012 1.5 mg SC Q3W + SoC IV in first-line PD-L1 negative NSQ NSCLC |
|
|
Active Comparator Phase 2: Arm C |
SoC IV in first-line PD-L1 negative NSQ NSCLC |
|
Recruiting Locations
Boston 4930956, Massachusetts 6254926 02114
More Details
- Status
- Recruiting
- Sponsor
- Synthekine
Detailed 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.