A Pilot Study of DSP-0390 in Combination With Atezolizumab as Maintenance Therapy for Extensive Stage Small Cell Lung Cancer
Washington University School of Medicine
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed small cell lung cancer. * Completed 3-4 cycles of induction chemoimmunotherapy as first line treatment of ES-SCLC without disease progression. * Measurable disease per RECIST 1.1. * At least 18 years of age. * ECOG performance status ≤ 2 * Adequate bone marrow and organ function as defined below: * Absolute neutrophil count ≥ 1.0 K/cumm * Platelets ≥ 100 K/cumm * Hemoglobin ≥ 8.0 g/dL * Total bilirubin ≤ 1.5 x IULN * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN (≤ 5.0 x IULN for patients with liver metastases) * Calculated creat…
Interventions
- DrugDSP-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.
- DrugAtezolizumab
Atezolizumab will be given per standard of care. FDA-approved dosing is 1200 mg intravenously (IV) every three weeks.
Location
- Washington University School of MedicineSt Louis, Missouri