DSP-0390 in Combination With Atezolizumab for Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition (following discussion with the PI) are eligible for this trial
Currently receiving any other investigational agents, or received within 4 weeks prior to Day 1 (unless investigational immunotherapy, which may not have been received within 6 weeks prior to Day 1).
Patients with untreated symptomatic brain metastases or with clinically evident CNS hemorrhage. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic, punctate brain metastases < 5 mm are allowed.
Known contraindications to use of PD-L1 inhibitor as assessed by the treating physician.
Trial design
Treatments tested in this trial
- DSP-0390
- Atezolizumab
Treatment groups
20 Participants
are divided into 3 treatment groupsSponsors and collaborators
Washington University School of Medicine
Lead sponsor
Sumitomo Pharma America, Inc.
Collaborator
Source ClinicalTrials.gov