NCT03144245

Study of AMV564 in Patients With AML

A Phase 1, First in Human, Open Label, Dose Escalation Study of AMV564, a CD33 x CD3 Tandem Diabody in Patients With Relapsed or Refractory Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Amphivena Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first in human, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of AMV564.

Detailed description

This study is a first in human, Phase 1, open label, multicenter, dose escalation study with expansion at the RP2D to evaluate the safety, tolerability and preliminary antileukemic activity of AMV564 in patients with relapsed or refractory acute myeloid leukemia (AML). AMV564 will be given on Days 1-14 of a 4-week cycle, or Days 1-28 of a 6-week cycle,via CIV or subcutaneous administration for 1 or more treatment cycles as monotherapy or in combination with pembrolizumab.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	AMV564	AMV564 for administration via continuous intravenous daily infusion or subcutaneous dosing
COMBINATION_PRODUCT	AMV564 in combination with pembrolizumab	AMV564 for administration via continuous intravenous daily infusion or subcutaneous dosing.in combination with pembrolizumab given IV every 21 days

Timeline

• Start date: 2017-03-20
• Primary completion: 2020-07-21
• Completion: 2020-11-05
• First posted: 2017-05-08
• Last updated: 2021-10-12

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study