NCT04402541

Study of CB-5339 in Acute Myeloid Leukemia or Myelodysplastic Syndrome

A Phase 1 Study to Evaluate the Safety and Pharmacokinetic Profiles of CB-5339 in Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed/Refractory Intermediate or High Risk Myelodysplastic Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Cleave Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label Phase 1 study of orally administered CB-5339 in participants with R/R AML or participants with R/R intermediate- to high-risk MDS.

Detailed description

This is a multicenter, open-label Phase 1 study of orally administered CB-5339 in participants with R/R AML or participants with R/R intermediate- to high-risk MDS. The study will include two parts:1) a Dose Escalation phase in participants with R/R AML, or R/R intermediate- to high-risk MDS and 2) a Dose Expansion phase in participants with R/R AML for whom there is no standard of care therapy available that is likely to lead to disease remission. Additional cohorts for participants with R/R intermediate- to high-risk MDS following hypomethylating agents or other AML cohorts may be added at a later time.

Conditions

• Acute Myeloid Leukemia, in Relapse
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	CB-5339	25mg and 75mg capsules

Timeline

• Start date: 2020-06-08
• Primary completion: 2023-07-23
• Completion: 2023-07-23
• First posted: 2020-05-27
• Last updated: 2023-08-31

Locations

10 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study