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

Withdrawn before enrolling · Phase 1

Conditions studied: 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

In brief

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

Key facts

Study ID: NCT06291415
Run by: Hutchmed
People needed: 0
Starts: 2024-04-02
Expected to finish: 2026-11-01
Last updated by the study team: 2025-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects may be enrolled in this study only if they satisfy all the following criteria:
Adult male or female subjects ≥18 years of age
Diagnosis of ITP, with a duration of disease of at least 3 months prior to randomization or enrollment
Intolerance or insufficient response or recurrence after at least 1 prior ITP treatment (excluding splenectomy)
Response (defined as achieved a platelet count ≥50 × 109/L) to at least 1 prior ITP therapy (including splenectomy)
Adequate hematologic, hepatic and renal function

You may not qualify if…

Subjects are not eligible for enrollment into this study if any one of the following criteria are met:
Evidence of the presence of secondary causes of ITP
Clinically serious hemorrhage requiring immediate adjustment of platelets
Known history of vital organ transplantation or hematopoietic stem-cell transplantation or chimeric antigen receptor T-cells (CAR-T) therapy
Splenectomy within 12 weeks prior to enrollment
Presence of active malignancy unless deemed cured by adequate treatment.
History of serious cardiovascular disease corrected QT interval (QTcF) ≥450 ms
Uncontrolled hypertension
Being unsuitable to participate in this study as considered by investigators

Where it is running

Childrens Hospital of California — Irvine, California, United States
Georgetown University Medical Center - Georgetown Lombardi Comprehensive Cancer Center — Georgetown, Delaware, United States
Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
San Juan Oncology Associates — Farmington, New Mexico, United States
East Carolina University, Brody School of Medicine — Greenville, North Carolina, United States
Taussig Cancer Institute — Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute — Tulsa, Oklahoma, United States
Texas Oncology San Antonio Medical Center — San Antonio, Texas, United States
University of Washington (UW) Medical Center — Seattle, Washington, United States
Peninsula Private Hospital — Frankston, Victoria, Australia
The Perth Blood Institute (PBI) Hollywood Specialist Centre — West Perth, Western Australia, Australia
Royal Adelaide Hospital — Adelaide, Australia
Canberra Hospital — Canberra, Australia
Charite university — Berlin, Germany
Marien Hospital Dusseldorf — Düsseldorf, Germany
UMG Gottingen Hämatologie — Göttingen, Germany
University Hospital of Schleswig-Holstein, Department of Haematology and Oncology — Lübeck, Germany
Sykehuset Ostfold Kalnes (fosta) / Osfold Hospital Trust (MSL) — Grålum, Norway
Oslo University Hospital — Oslo, Norway
Hospital del Mar Barcelona — Barcelona, Spain
Hospital Universitari Vall d'Hebron — Barcelona, Spain
University de Burgos — Burgos, Spain
Hospital Gregorio Maranon Madrid — Madrid, Spain
Clinica Universidad de Navarra — Madrid, Spain

Full record on ClinicalTrials.gov

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