A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
- Conditions
- Acute Myeloid LeukemiaAML, Adult
- Interventions
- Registration Number
- NCT04755244
- Lead Sponsor
- ALX Oncology Inc.
- Brief 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).
- Detailed 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. While intended to be a Phase 1/2 clinical study, the study never moved forward to Phase 2.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description evorpacept (ALX148) + venetoclax + azacitidine venetoclax Phase 1a: Participants will receive escalating doses of evorpacept (ALX148) in combination with venetoclax and azacitidine Phase 1b/2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with venetoclax and azacitidine. evorpacept (ALX148) + venetoclax + azacitidine azacitidine Phase 1a: Participants will receive escalating doses of evorpacept (ALX148) in combination with venetoclax and azacitidine Phase 1b/2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with venetoclax and azacitidine. evorpacept (ALX148) + venetoclax + azacitidine evorpacept Phase 1a: Participants will receive escalating doses of evorpacept (ALX148) in combination with venetoclax and azacitidine Phase 1b/2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with venetoclax and azacitidine.
- Primary Outcome Measures
Name Time Method Phase 1: Dose Limiting Toxicities (DLT) Up to 28 days Number of participants with a DLT
Phase 2: Composite complete remission rate (CRc) Approximately 6 months Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2017 criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Northwestern University Feinberg School of Medicine🇺🇸Chicago, Illinois, United States