DSP-0390 in Combination With Atezolizumab for Small Cell Lung Cancer

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07545954
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Small Cell Lung Cancer Extensive Stage
  • Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DSP-0390 — DRUG
    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.
  • Atezolizumab — DRUG
    Atezolizumab will be given per standard of care. FDA-approved dosing is 1200 mg intravenously (IV) every three weeks.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead-In: Dose Level 1 DSP-390 + Atezolizumab
    DSP-0390 will be administered as 180 mg orally each day of a 21-day cycle. Atezolizumab will be administered per standard of care and dosing is not dictated by this study. Treatment will continue until disease progression or unacceptable toxicity, for a maximum of 2 years.
  • Experimental: Safety Lead-In: Dose level -1 DSP-390 + Atezolizumab
    DSP-0390 will be administered at 120 mg orally each day of a 21-day cycle. Atezolizumab will be administered per standard of care and dosing is not dictated by this study. Treatment will continue until disease progression or unacceptable toxicity, for a maximum of 2 years.
  • Experimental: Determined safe dose: DSP-0390 + Atezolizumab
    DSP-0390 will be administered at the determined safe dose orally each day of a 21-day cycle. Atezolizumab will be administered per standard of care and dosing is not dictated by this study. Treatment will continue until disease progression or unacceptable toxicity, for a maximum of 2 years.

Primary Outcome Measure

Incidence of treatment-emergent adverse events [ Time Frame: Until 30 days after completion of treatment (estimated time to be 2 years and 30 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Ece Cali Daylan, MD, PhD
[email protected]
314-273-8008
Ece Cali Daylan, MD, PhD (PRINCIPAL_INVESTIGATOR)
Ramaswamy Govindan, MD (SUB_INVESTIGATOR)
Feng Gao, PhD (SUB_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MO

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