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A Study of ALX148 With Azacitidine for Higher Risk Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417517
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
ALX Oncology Inc.

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

Condition or disease Intervention/treatment Phase
Higher Risk Myelodysplastic Syndromes Drug: ALX148 Drug: Azacitidine Phase 1 Phase 2

Detailed Description:
The Phase 1 will consist of a dose escalation of 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 ALX148 in combination with azacitidine for patients with higher risk MDS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of ALX148 in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS)
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine

Arm Intervention/treatment
Experimental: ALX148 + azacitidine

Phase 1: Participants will receive escalating doses of ALX148 in combination with azacitidine (75 mg/m2 IV or subcutaneous daily for 7 days of a 28 day cycle)

Phase 2: Participants will receive ALX148 at the recommended Phase 2 dose in combination with azacitidine (75 mg/m2 IV or subcutaneous daily for 7 days of a 28 day cycle)

Drug: ALX148
Fusion protein that inhibits the CD47-SIRPalpha signaling pathway

Drug: Azacitidine
Hypomethylating agent (HMA)
Other Name: Vidaza




Primary Outcome Measures :
  1. Phase 1: Dose Limiting Toxicities (DLT) [ Time Frame: Up to 28 days ]
    Number of participants with a DLT

  2. Phase 2: Objective response rate (ORR) [ Time Frame: Approximately 6 months ]
    Number of participants achieving a response per International Working Group (IWG) criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417517


Contacts
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Contact: Abraham Fong, MD, PhD (650)466-7125 info@alxoncology.com

Sponsors and Collaborators
ALX Oncology Inc.
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Responsible Party: ALX Oncology Inc.
ClinicalTrials.gov Identifier: NCT04417517    
Other Study ID Numbers: AT148002
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ALX Oncology Inc.:
ALX148
Higher risk MDS
CD47
Azacitidine
HMA
SIRP-alpha
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors