A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Venetoclax and Azacitidine in Patients With Acute Myeloid Leukemia (AML) (ASPEN-05)
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- ALX Oncology Inc.
- Enrollment
- 14
- Locations
- 5
- Primary Endpoint
- Phase 1: Dose Limiting Toxicities (DLT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
evorpacept (ALX148) + venetoclax + 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.
Intervention: evorpacept (Drug)
evorpacept (ALX148) + venetoclax + 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.
Intervention: venetoclax (Drug)
evorpacept (ALX148) + venetoclax + 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.
Intervention: azacitidine (Drug)
Outcomes
Primary Outcomes
Phase 1: Dose Limiting Toxicities (DLT)
Time Frame: Up to 28 days
Number of participants with a DLT
Phase 2: Composite complete remission rate (CRc)
Time Frame: 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 Outcomes
No secondary outcomes reported