Hemorrhage Clinical Trial
Official title:
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
Verified date | June 2024 |
Source | Hutchmed |
Contact | Nick Lawn |
Phone | +1-973-306-4490 |
2022-523-GLOB1[@]hutch-med.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | November 2026 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Subjects may be enrolled in this study only if they satisfy all the following 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: Subjects are not eligible for enrollment into this study if any one of the following criteria are met: 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | |
Australia | Canberra Hospital | Canberra | |
Australia | Peninsula Private Hospital | Frankston | Victoria |
Australia | The Perth Blood Institute (PBI) Hollywood Specialist Centre | West Perth | Western Australia |
Germany | 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 | |
Norway | Sykehuset Ostfold Kalnes (fosta) / Osfold Hospital Trust (MSL) | Grålum | |
Norway | Oslo University Hospital | Oslo | |
Spain | Hospital del Mar Barcelona | Barcelona | |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
Spain | University de Burgos | Burgos | |
Spain | Clinica Universidad de Navarra | Madrid | |
Spain | Fundacion Jimenez Diaz | Madrid | |
Spain | Hospital Gregorio Maranon Madrid | Madrid | |
Spain | Hospital Infanta Leonor | Madrid | |
Spain | Hospital Morales Meseguer | Murcia | |
United States | Center for Cancer and Blood Disorders | Bethesda | Maryland |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Taussig Cancer Institute | Cleveland | Ohio |
United States | San Juan Oncology Associates | Farmington | New Mexico |
United States | Georgetown University Medical Center - Georgetown Lombardi Comprehensive Cancer Center | Georgetown | Delaware |
United States | East Carolina University, Brody School of Medicine | Greenville | North Carolina |
United States | Childrens Hospital of California | Irvine | California |
United States | Texas Oncology San Antonio Medical Center | San Antonio | Texas |
United States | University of Washington (UW) Medical Center | Seattle | Washington |
United States | Oklahoma Cancer Specialists and Research Institute | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Hutchmed |
United States, Australia, Germany, Norway, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of HMPL-523 in adult subjects with primary ITP | Calculated as the number and percent incidence of participants experiencing adverse events (AE). | week 1 - week 24 | |
Primary | Dose Limiting Toxicities | Defined as an adverse event AE that meets protocol defined Dose Limiting Toxicities (DLT) criteria during the DLT assessment window (first 28 days), unless clearly unrelated to ITP drugs. | week 1 - week 4 | |
Secondary | Cmax (maximum plasma drug concentration) | Blood samples will be obtained from all patients to determine maximum plasma drug concentration of HMPL-523 and metabolite M | week 1 and week 3 | |
Secondary | AUCtau (area under the concentration-time curve over a dosage interval) | Blood samples will be obtained from all patients to determine area under the concentration time curve over periodic dosing intervals for HMPL-523 and metabolite M1 | week 1 and week 3 | |
Secondary | Tmax (time to reach maximum plasma drug concentration) | Blood samples will be obtained from all patients to determine time to reach maximum plasma concentration of HMPL-523 and metabolite M1 | week 1 and week 3 | |
Secondary | Cmin (minimum plasma drug concentration) | Blood samples will be obtained from all patients to determine minimum plasma concentration of HMPL-523 and metabolite M1 | week 1 - week 20 |
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