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

Amphivena Therapeutics

Status and phase: Completed; Phase 1

Conditions: Myelodysplastic Syndrome (MDS)

Treatments: Drug: AMV564 14-Day CIV

Study type: Interventional

Funder types: Industry

Identifiers

NCT03516591

AMV564-201

Details and patient eligibility

About

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

Full description

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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Dose Escalation (3+3 design)

Experimental group

Description:

A 3 + 3 design, with dose-escalation of AMV564, up to a Maximum Tolerated Dose (MTD) level. AMV564 will be tested as a 14-Day CIV regimen (14-Day Continuous Intravenous Infusion Regimen).

Treatment:

Drug: AMV564 14-Day CIV

Dose Expansion

Experimental group

Description:

Following determination of the MTD of AMV564, the study will expand at the MTD or a dose level lower than the MTD to obtain initial estimates of response rates and additional information on safety.

Treatment:

Drug: AMV564 14-Day CIV