The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)
NCT ID: NCT06291415
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2024-04-02
2026-11-30
Brief Summary
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Detailed Description
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In the dose escalation stage (Part 1), subjects will receive one of 3 dose levels of HMPL-523 to determine the recommended dose of HMPL-523 for the randomized dose optimization- stage (Part 2).
At the end of Part 1, 2 dose levels will be selected to be used in the dose-optimization stage (Part 2) of the study. In Part 2 of the study, subjects will be randomized in a 1:1 ratio between the 2 dose levels to better understand the exposure/efficacy/toxicity relationship.
At the end of Part 2, the Recommended Phase 3 dose (RP3D) of HMPL-523 will be determined based on the safety, efficacy and PK data.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Part 2: subjects will be randomized in a 1:1 ratio between the 2 dose levels recommended by the SRC to better understand the exposure/efficacy/toxicity relationship. At the end of Part 2, the SRC will evaluate the safety, tolerability, preliminary efficacy, and PK data to determine the Recommended Phase 3 dose (RP3D) of HMPL-523.
TREATMENT
NONE
Study Groups
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Dose escalation
Part 1 will consist of the following 3 dose levels: 300, 400, and 500 mg once daily (QD).
HMPL-523
Syk inhibitor
Dose optimization stage
In part 2 subjects will be randomized in a 1:1 ratio between the 2 dose levels selected at the end of part 1.
HMPL-523
Syk inhibitor
Interventions
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HMPL-523
Syk inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Hutchmed
INDUSTRY
Responsible Party
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Principal Investigators
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William Schelman, MD, PhD
Role: STUDY_DIRECTOR
Hutchmed
Locations
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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
Hospital Infanta Leonor
Madrid, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Morales Meseguer
Murcia, , Spain
Countries
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Other Identifiers
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2022-523-GLOB1
Identifier Type: -
Identifier Source: org_study_id
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