The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)

Description

This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.

Conditions

Immune Thrombocytopenia, Blood Platelet Disorder, Hematologic Diseases, Purpura, Thrombocytopenic, Purpura, Blood Coagulation Disorder, Thrombotic Microangiopathies, Hemorrhagic Disorders, Autoimmune Diseases, Immune System Diseases, Hemorrhage, Pathologic Processes, Skin Manifestations, Thrombocytopenia, Purpura, Thrombocytopenic, Idiopathic, Primary Immune Thrombocytopenia, ITP - Immune Thrombocytopenia

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Study Overview

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Study Details

Study overview

This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.

A Multicenter, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523, a Syk Inhibitor, in Adult Subjects With Immune Thrombocytopenia

The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)

Condition
Immune Thrombocytopenia
Intervention / Treatment

-

Contacts and Locations

Irvine

Childrens Hospital of California, Irvine, California, United States, 92868

Georgetown

Georgetown University Medical Center - Georgetown Lombardi Comprehensive Cancer Center, Georgetown, Delaware, United States, 20007

Bethesda

Center for Cancer and Blood Disorders, Bethesda, Maryland, United States, 20817

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Farmington

San Juan Oncology Associates, Farmington, New Mexico, United States, 87401

Greenville

East Carolina University, Brody School of Medicine, Greenville, North Carolina, United States, 27834

Cleveland

Taussig Cancer Institute, Cleveland, Ohio, United States, 44106

Tulsa

Oklahoma Cancer Specialists and Research Institute, Tulsa, Oklahoma, United States, 74146

San Antonio

Texas Oncology San Antonio Medical Center, San Antonio, Texas, United States, 78240

Seattle

University of Washington (UW) Medical Center, Seattle, Washington, United States, 98195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Adult male or female subjects ≥18 years of age
  • 2. Diagnosis of ITP, with a duration of disease of at least 3 months prior to randomization or enrollment
  • 3. Intolerance or insufficient response or recurrence after at least 1 prior ITP treatment (excluding splenectomy)
  • 4. Response (defined as achieved a platelet count ≥50 × 109/L) to at least 1 prior ITP therapy (including splenectomy)
  • 5. Adequate hematologic, hepatic and renal function
  • 1. Evidence of the presence of secondary causes of ITP
  • 2. Clinically serious hemorrhage requiring immediate adjustment of platelets
  • 3. Known history of vital organ transplantation or hematopoietic stem-cell transplantation or chimeric antigen receptor T-cells (CAR-T) therapy
  • 4. Splenectomy within 12 weeks prior to enrollment
  • 5. Presence of active malignancy unless deemed cured by adequate treatment.
  • 6. History of serious cardiovascular disease corrected QT interval (QTcF) ≥450 ms
  • 7. Uncontrolled hypertension
  • 8. Being unsuitable to participate in this study as considered by investigators

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hutchmed,

William Schelman, MD, PhD, STUDY_DIRECTOR, Hutchmed

Study Record Dates

2026-11