The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)
Megadott ok: Sponsor decision
A legfontosabb adatok
- Hol
- Bethesda, Boston, Cleveland, Farmington, Georgetown, Greenville, Irvine, San Antonio, Seattle és Tulsa (Egyesült Államok)Mind a 10 helyszín megnézése
- Fázis
- 1. fázis
Helyszínek itt: Egyesült Államok
- Center for Cancer and Blood DisordersBethesda, Egyesült ÁllamokNo longer taking part
- Massachusetts General HospitalBoston, Egyesült ÁllamokNo longer taking part
- Taussig Cancer InstituteCleveland, Egyesült ÁllamokNo longer taking part
- San Juan Oncology AssociatesFarmington, Egyesült ÁllamokNo longer taking part
- Georgetown University Medical Center - Georgetown Lombardi Comprehensive Cancer CenterGeorgetown, Egyesült ÁllamokNo longer taking part
- East Carolina University - Brody School of MedicineGreenville, Egyesült ÁllamokNo longer taking part
- Childrens Hospital of CaliforniaIrvine, Egyesült ÁllamokNo longer taking part
- Texas Oncology - San Antonio Medical CenterSan Antonio, Egyesült ÁllamokNo longer taking part
- University of Washington (UW) Medical CenterSeattle, Egyesült ÁllamokNo longer taking part
- Oklahoma Cancer Specialists and Research InstituteTulsa, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Hutchmed
- Azonosító
- NCT06291415
- A regiszteradat frissítve
- 2025. szeptember 16.
- Eredeti leírás
This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.