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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06291415
Other study ID # 2022-523-GLOB1
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 2, 2024
Est. completion date November 2026

Study information

Verified date June 2024
Source Hutchmed
Contact Nick Lawn
Phone +1-973-306-4490
Email 2022-523-GLOB1@hutch-med.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

This study is a Phase 1b, open-label, multicenter, single-arm study to evaluate the safety, tolerability, and preliminary efficacy of HMPL-523 in adult subjects with primary ITP diagnosed at least 3 months prior to enrollment or randomization. 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
HMPL-523
Syk inhibitor

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hutchmed

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Norway,  Spain, 

Outcome

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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