A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
ALX Oncology Inc.
Study ID
NCT04755244
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • evorpacept — DRUG
    Fusion protein that blocks CD47-SIRPalpha pathway
  • venetoclax — DRUG
    BCL-2 inhibitor
  • azacitidine — DRUG
    Hypomethylating agent (HMA)

Study Details

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).

Key Dates

Start date
May 5, 2021
Status verified
Aug 2023
Primary completion
May 5, 2023
Completion
Aug 16, 2023

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Phase 1: Dose Limiting Toxicities (DLT) [ Time Frame: Up to 28 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
Northwestern University Feinberg School of MedicineChicagoIllinois60611-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Duke University Medical CenterDurhamNorth Carolina27710-
Vanderbilt University Medical CenterNashvilleTennessee37203-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Chicago, IL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Northwestern University Feinberg School of Medicine· Chicago, ILRoswell Park Comprehensive Cancer Center· Buffalo, NYDuke University Medical Center· Durham, NCVanderbilt University Medical Center· Nashville, TNUniversity of Texas MD Anderson Cancer Center· Houston, TX

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