The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)
Reason given: Sponsor decision
Key facts
- Where
- Bethesda, Boston, Cleveland, Farmington, Georgetown, Greenville, Irvine, San Antonio, Seattle, and Tulsa, United StatesSee the 10 sites
- Phase
- Phase 1
Where in United States
- Center for Cancer and Blood DisordersBethesda, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Taussig Cancer InstituteCleveland, United StatesNo longer taking part
- San Juan Oncology AssociatesFarmington, United StatesNo longer taking part
- Georgetown University Medical Center - Georgetown Lombardi Comprehensive Cancer CenterGeorgetown, United StatesNo longer taking part
- East Carolina University - Brody School of MedicineGreenville, United StatesNo longer taking part
- Childrens Hospital of CaliforniaIrvine, United StatesNo longer taking part
- Texas Oncology - San Antonio Medical CenterSan Antonio, United StatesNo longer taking part
- University of Washington (UW) Medical CenterSeattle, United StatesNo longer taking part
- Oklahoma Cancer Specialists and Research InstituteTulsa, United StatesNo longer taking part
Trial details
- Who runs it
- Hutchmed
- Trial code
- NCT06291415
- Record updated
- 16 September 2025
- Original description
This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.Read full original descriptionShow less
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
This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.
Inclusion: 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.
Exclusion: Splenectomy within 12 weeks prior to enrollment; Known history of vital organ transplantation or hematopoietic stem-cell transplantation or chimeric antigen receptor T-cells (CAR-T) therapy; Presence of active malignancy unless deemed cured by adequate treatment; Uncontrolled hypertension; Clinically serious hemorrhage requiring immediate adjustment of platelets; History of serious cardiovascular disease corrected QT interval (QTcF) ≥450 ms; 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; Being unsuitable to participate in this study as considered by investigators.