Clinical trial NCT04755244: A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
Official title: A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Venetoclax and Azacitidine in Patients With Acute Myeloid Leukemia (AML) (ASPEN-05)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
AML, Adult
Keywords: ALX148
CD47
SIRPalpha
azacitidine
venetoclax
evorpacept
Lead sponsor: ALX Oncology Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Phase 1: Dose Limiting Toxicities (DLT)
timeFrame: Up to 28 days
measure: Phase 2: Composite complete remission rate (CRc)
timeFrame: Approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References: