Clinical trial NCT04417517: A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)
Official title: A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Higher Risk Myelodysplastic Syndromes
Keywords: ALX148
MDS
CD47
Azacitidine
HMA
SIRP-alpha
evorpacept
High risk
Lead sponsor: ALX Oncology Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).

Detailed description: The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose of ALX148 in combination with azacitidine. The Phase 2 will evaluate the efficacy of evorpacept (ALX148) in combination with azacitidine compared to azacitidine alone for patients with previously untreated higher risk MDS.

Eligibility criteria: Inclusion Criteria:

* Phase 1: Diagnosis of higher risk MDS that is either previously untreated or relapsed/refractory.
* Phase 2: Diagnosis of higher risk MDS that is previously untreated.
* Adequate renal and liver function.
* Age ≥18 years.
* Adequate performance status.

Exclusion Criteria:

* Previous allogeneic hematopoietic stem cell transplant (allo-HSCT) for MDS or AML.
* Prior treatment with any anti-CD47 or anti-SIRPα (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 1: Recommended Phase 2 Dose (RP2D)
timeFrame: Approximately 2 years
measure: Phase 2: Complete response rate (CRR)
timeFrame: Approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California, Norris Comprehensive Cancer Center
state: California
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: IU Simon Cancer Center
state: Indiana
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
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
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
Study officials:
References: