Trials / Recruiting
RecruitingNCT05098132
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 364 (estimated)
- Sponsor
- Synthekine · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | STK-012 | Engineered Interleukin-2 (IL-2) selective for antigen activated T cells |
| DRUG | pembrolizumab | anti-PD-1 monoclonal antibody |
| DRUG | pemetrexed | chemotherapy |
| DRUG | carboplatin | chemotherapy |
Timeline
- Start date
- 2022-01-25
- Primary completion
- 2029-01-01
- Completion
- 2029-01-01
- First posted
- 2021-10-28
- Last updated
- 2026-03-18
Locations
27 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05098132. Inclusion in this directory is not an endorsement.