WITHDRAWN

The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)

Conditions

Immune Thrombocytopenia Blood Platelet Disorder Hematologic Diseases Purpura, Thrombocytopenic Purpura Blood Coagulation Disorder Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases Hemorrhage Pathologic Processes Skin Manifestations Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic Primary Immune Thrombocytopenia ITP - Immune Thrombocytopenia ITP sovleplenib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-04-02

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:WITHDRAWN

Study ID

NCT06291415

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

William Schelman, MD, PhD

STUDY_DIRECTOR

Hutchmed

Study Locations (Sites)

Childrens Hospital of California

Irvine, California, 92868

United States

Georgetown University Medical Center - Georgetown Lombardi Comprehensive Cancer Center

Georgetown, Delaware, 20007

United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

San Juan Oncology Associates

Farmington, New Mexico, 87401

United States

East Carolina University, Brody School of Medicine

Greenville, North Carolina, 27834

United States

Taussig Cancer Institute

Cleveland, Ohio, 44106

United States

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 74146

United States

Texas Oncology San Antonio Medical Center

San Antonio, Texas, 78240

United States

University of Washington (UW) Medical Center

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Hutchmed

William Schelman, MD, PhD, STUDY_DIRECTOR, Hutchmed

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-02

Study Completion Date2026-11

Study Record Updates

Study Start Date2024-04-02

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

ITP
sovleplenib

Additional Relevant MeSH Terms

Immune Thrombocytopenia
Blood Platelet Disorder
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorder
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Primary Immune Thrombocytopenia
ITP - Immune Thrombocytopenia