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



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:June 22, 2018
End Date:May 2020
Contact:Clinical Operations
Email:clinical@amphivena.com
Phone:1-833-AMPHITX (267-4489)

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A Phase 1, Multicenter, Open Label Study of AMV564, a Bispecific CD33/CD3 T-cell Engager, in Patients With Intermediate or High-Risk Myelodysplastic Syndromes

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

A dose-escalation with expansion study of AMV564 (T cell engager) as monotherapy in patients
with intermediate-2 or high-risk Myelodysplastic Syndromes

Inclusion Criteria:

- ≥ 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.

Exclusion Criteria:

- 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).
We found this trial at
3
sites
Houston, Texas 77030
Principal Investigator: Guillermo Garcia-Manero, MD
Phone: 713-792-5615
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Meagan Jacoby, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Tampa, Florida 33612
Principal Investigator: David Sallman, MD
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Tampa, FL
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