DSP-0390 + Atezolizumab for Small Cell Lung Cancer

Overseen By Ece Cali Daylan, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington University School of Medicine

Must not be taking: Carbamazepine, Phenytoin, Phenobarbital, others

Disqualifiers: Symptomatic brain metastases, Uncontrolled illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 21

Duration: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Ece Cali Daylan, MD, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

Measurable disease per RECIST 1.1

Agree to use adequate contraception if of childbearing potential or able to father a child

I understand the study and am willing to sign a consent form.

Exclusion Criteria

History of allergic reactions to compounds of similar composition to DSP-0390 or atezolizumab

I do not have another cancer that could affect this study's results.

I have a known reason why I cannot take PD-L1 inhibitor medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-In

Evaluation of safety and preliminary efficacy of DSP-0390 in combination with atezolizumab

21-day cycles, up to 2 years

Regular visits per 21-day cycle

Treatment

DSP-0390 administered daily with atezolizumab until disease progression or unacceptable toxicity

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• DSP-0390

How Is the Trial Designed?

Group I: Safety Lead-In: Dose level -1 DSP-390 + Atezolizumab Experimental Treatment 2 Interventions

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.

Group II: Safety Lead-In: Dose Level 1 DSP-390 + Atezolizumab Experimental Treatment 2 Interventions

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.

Group III: Determined safe dose: DSP-0390 + Atezolizumab Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Sumitomo Pharma America, Inc.

Industry Sponsor

Trials

244

Recruited

51,500+

Jatin Shah

Sumitomo Pharma America, Inc.

Chief Medical Officer since 2024

MD from an unspecified institution

Tsutomu Nakagawa

Sumitomo Pharma America, Inc.

Chief Executive Officer since 2024

MBA from Waseda University