A Phase 1 Study of AMV564 in Patients With Intermediate or High-Risk Myelodysplastic Syndromes

Completed · Phase 1

Conditions studied: Myelodysplastic Syndrome (MDS)

In brief

An open label, Phase 1, study of AMV564 as monotherapy to assess the safety and efficacy in patients with Myelodysplastic Syndromes

Key facts

Study ID

NCT03516591

Run by

Amphivena Therapeutics, Inc.

People needed

14

Starts

2018-06-22

Expected to finish

2020-07-31

Last updated by the study team

2021-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age
• Diagnosis of MDS according to WHO 2016 criteria
• ECOG performance status of 0 or 1
• Intermediate-2 or high-risk disease per IPSS
• Fewer than 20% blasts in the bone marrow or peripheral blood
• Disease that is refractory to or relapsed from either a hypomethylating agent (e.g. decitabine or azacitidine) or a standard AML-type intensive regimen
• Adequate organ function
• Prior allogeneic transplant performed ≥ 3 months prior to first dose of AMV564 is allowed provided there is no evidence of active graft-versus-host disease (GVHD) and the patient has been off immunosuppressive therapy for ≥ 4 weeks.

You may not qualify if…

• History of, or known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ≥ 3 drug-related CNS toxicity
• Prior allogeneic transplant if performed < 3 months prior to first dose of AMV564, if patient has active GVHD, or if patient has not been off immunosuppressive
• Prior treatment with a therapeutic agent targeting CD33 (e.g. gemtuzumab ozogamicin, SGN-CD33A or AMG 330).

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Washington University, Siteman Cancer Center — St Louis, Missouri, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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