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

NCT ID: NCT03516591

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-22
• Study Completion Date: 2020-07-31

Brief Summary

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

Detailed Description

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

Conditions

Myelodysplastic Syndrome (MDS)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation (3+3 design)

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).

Group Type: EXPERIMENTAL

AMV564 14-Day CIV

Intervention Type: DRUG

A 14-Day Continuous Intravenous Infusion regimen

Dose Expansion

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.

Group Type: EXPERIMENTAL

AMV564 14-Day CIV

Intervention Type: DRUG

A 14-Day Continuous Intravenous Infusion regimen

Interventions

AMV564 14-Day CIV

A 14-Day Continuous Intravenous Infusion regimen

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amphivena Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Chun, MD

Role: STUDY_DIRECTOR

Amphivena Therapeutics, Inc.

Locations

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

Countries

United States

Other Identifiers

AMV564-201

Identifier Type: -

Identifier Source: org_study_id