DSP-0390 / Sumitomo Pharma - LARVOL DELTA

Window of Opportunity Study of DSP-0390 in Gliomas (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Washington University School of Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • CNS Tumor • Glioma • Malignant Glioma • Oncology • Solid Tumor

Window of Opportunity Study of DSP-0390 in Gliomas (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Washington University School of Medicine

New P1 trial • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Study of DSP-0390 in Patients with Recurrent High-Grade Glioma (clinicaltrials.gov) - P1 | N=39 | Active, not recruiting | Sponsor: Sumitomo Pharma America, Inc. | Trial completion date: Jul 2024 ➔ Oct 2026 | Trial primary completion date: Oct 2023 ➔ Sep 2026

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Study of DSP-0390 in Patients With Recurrent High-Grade Glioma (clinicaltrials.gov) - P1 | N=39 | Active, not recruiting | Sponsor: Sumitomo Pharma America, Inc. | Recruiting ➔ Active, not recruiting | N=70 ➔ 39 | Trial completion date: Mar 2025 ➔ Jul 2024 | Trial primary completion date: Nov 2024 ➔ Oct 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

First in human study of DSP-0390, an oral emopamil binding protein (EBP) inhibitor, in recurrent high-grade glioma (HGG): preliminary results (SNO 2023) - P1 | "DSP-0390 has been well tolerated to date with dose escalation ongoing. A dose response relationship was observed between PK and PD biomarkers."

P1 data • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor

DSP-0390, an oral emopamil binding protein (EBP) inhibitor, in patients with recurrent high-grade glioma: a first-in-human, phase 1 study (SNO 2022) - P1 | "Study endpoints include safety (treatment-emergent adverse events [AEs], serious AEs, and dose-limiting toxicities), efficacy (6-month progression-free survival [PFS], objective response, PFS, duration of response, and 12-month overall survival), pharmacokinetics (PK), and pharmacodynamic biomarkers. This study is currently recruiting in the United States and Japan."

Clinical • P1 data • Brain Cancer • Cardiovascular • Glioblastoma • Glioma • Hematological Disorders • Immunology • Oncology • Solid Tumor

DSP-0390, an oral emopamil binding protein (EBP) inhibitor, in patients with recurrent high-grade glioma: A first-in-human, phase 1 study. (ASCO 2022) - P1 | "Study endpoints include safety (treatment-emergent adverse events [AEs], serious AEs, and dose-limiting toxicities), efficacy (6-month progression-free survival [PFS], objective response, PFS, duration of response, and 12-month overall survival), pharmacokinetics (PK), and pharmacodynamic biomarkers. This study is currently recruiting in the United States and Japan."

Clinical • P1 data • Brain Cancer • Cardiovascular • Glioblastoma • Glioma • Hematological Disorders • Immunology • Oncology • Solid Tumor

FDA Grants Orphan Drug Designation to DSP-0390 in Brain Cancer (Targeted Oncology) - "'DSP-0390 is an emopamil-binding protein inhibitor that mediates de novo cholesterol synthesis for cell membrane structure and signaling, enabling aberrant growth of tumors,' added Jatin J. Shah, MD...'Notably, in patients with glioblastoma multiforme, a form of high-grade glioma, increased de novo cholesterol synthesis is correlated with poor survival and preclinical evidence has shown that DSP-0390 has cytotoxic activity against glioblastoma multiforme cell lines.'"

Media quote

Sumitomo Pharma Oncology Receives Orphan Drug Designation for DSP-0390, an Investigational Emopamil-binding Protein (EBP) Inhibitor for the Treatment of Brain Cancer (PRNewswire) - "Sumitomo Pharma Oncology, Inc...announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for DSP-0390, an investigational emopamil-binding protein (EBP) inhibitor for the treatment of brain cancer."

Orphan drug • Brain Cancer • CNS Tumor • Oncology

John Theurer Cancer Center Treats First Patient in U.S. with Investigational New Treatment for Brain Cancer (PRNewswire) - "John Theurer Cancer Center...announced today that it has treated the first patient in the country with DSP-0390, an investigational new drug for relapsed glioblastoma (GBM) and other anaplastic gliomas....DSP-0390, an investigational new agent developed by Cambridge, Massachusetts-based Sumitomo Dainippon Pharma Oncology, is an inhibitor of emopamil-binding protein (EBP), a molecule in cholesterol biosynthesis....This multicenter, global Phase 1/2 study is planned to enroll 70 patients at five brain tumor centers in the U.S. and Japan."

Trial status • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor