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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04755244
Other study ID # AT148005
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 5, 2021
Est. completion date December 2023

Study information

Verified date August 2023
Source ALX Oncology Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with venetoclax and azacitidine for the treatment of patients with acute myeloid leukemia (AML).


Description:

The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with venetoclax and azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose of evorpacept (ALX148) in combination with venetoclax and azacitidine. The Phase 2 will evaluate the efficacy of evorpacept (ALX148) in combination with venetoclax and azacitidine for patients with AML.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 97
Est. completion date December 2023
Est. primary completion date May 5, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Cytologically or histologically confirmed diagnosis of relapsed/refractory or newly diagnosed AML per WHO 2016 classification. - Phase 1a: AML that is relapsed/refractory or that is previously untreated in patients not considered suitable for intensive induction therapy. - Phase 1b: AML that is relapsed/refractory after prior treatment with a HMA-based regimen. - Phase 2: Previously untreated AML in patients who are not considered suitable candidates for intensive induction therapy. - Adequate renal and liver function. - Age =18 years. - Adequate performance status. Exclusion Criteria: - In Phase 1a and 1b, patients that have undergone prior allo-HSCT must be at least 3 months post-HSCT, without uncontrolled graft-versus-host disease (GVHD). For Phase 2, patients that have undergone prior allo-HSCT are excluded. - Patients with newly diagnosed AML with favorable risk cytogenetics such as t(8;21), inv(16), or t(16;16) as per the NCCN Guidelines Version 3, 2019 for AML. - Patients with acute promyelocytic leukemia (APL). - Prior treatment with any anti-CD47 or anti-SIRPalpha (signal regulatory protein alpha) agent. - Known active viral infections, including hepatitis B and C, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) related illness, or SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).

Study Design


Intervention

Drug:
evorpacept
Fusion protein that blocks CD47-SIRPalpha pathway
venetoclax
BCL-2 inhibitor
azacitidine
Hypomethylating agent (HMA)

Locations

Country Name City State
United States Roswell Park Comprehensive Cancer Center Buffalo New York
United States Northwestern University Feinberg School of Medicine Chicago Illinois
United States Duke University Medical Center Durham North Carolina
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
ALX Oncology Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1: Dose Limiting Toxicities (DLT) Number of participants with a DLT Up to 28 days
Primary Phase 2: Composite complete remission rate (CRc) Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2017 criteria Approximately 6 months
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