NCT04749355

Phase 2, Open-Label, Single Arm Study, With BST-236 in Adults With R/R AML or Higher-Risk MDS

A Phase 2, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults Unfit for Intensive Chemotherapy With Relapsed or Refractory AML or Higher-Risk Myelodysplastic Syndromes

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: BioSight Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open label multi center study to assess the safety and efficacy of BST-236 as single agent in adult patients unfit for standard therapy with Acute Myeloid Leukemia (AML) or higher-risk (HR) Myelodysplastic Syndromes (MDS) who fail to respond or relapsed following first line therapy. Approximately 20 adult patients with relapsed and/or refractory AML and approximately 20 adult patients with relapsed and/or refractory HR MDS, will be enrolled into the study. Patients will be treated with 1-2 induction courses and 2-4 maintenance courses. All patients will be followed for 1 year in the study and additional 1 year post study follow-up.

Conditions

• AML, Adult
• MDS
• Relapse/Recurrence
• Refractory Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	BST-236	BST-236 is a conjugate of cytarabine and asparagine, provided as a sterile lyophilized powder for IV administration

Timeline

• Start date: 2021-11-14
• Primary completion: 2023-12-14
• Completion: 2024-03-14
• First posted: 2021-02-11
• Last updated: 2023-03-09

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study