DSP-0390 in Combination With Atezolizumab for Small Cell Lung Cancer
NCT07545954 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-04-22
Summary
This is a single center pilot, phase Ib study with a safety lead-in evaluating the safety and preliminary efficacy of the EBP inhibitor DSP-0390 in combination with atezolizumab in patients with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after initial induction therapy with platinum-based chemotherapy and anti-PD-L1 immunotherapy (atezolizumab or durvalumab per treating physician's discretion). This trial is testing the hypothesis that inhibition of de novo cholesterol synthesis by DSP-0390 when used in combination with atezolizumab in the maintenance therapy of patients with ES-SCLC will be tolerable.
Conditions
- Small-cell Lung Cancer
- Small Cell Lung Cancer Extensive Stage
Interventions
- DRUG
-
DSP-0390
Patients should take DSP-0390 once a day at approximately the same time every day. DSP-0390 may be taken before or after atezolizumab on days when both drugs are given.
- DRUG
-
Atezolizumab will be given per standard of care. FDA-approved dosing is 1200 mg intravenously (IV) every three weeks.
Sponsors & Collaborators
-
Sumitomo Pharma America, Inc.
collaborator INDUSTRY -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Ece Cali Daylan, MD, PhD · Washington University School of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2029-08-31
- Completion
- 2030-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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