Immune ThrombocytopeniaPhase 1NCT06291415

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

A Phase 1 study testing HMPL-523 in people with Immune Thrombocytopenia and Blood Platelet Disorder, run by Hutchmed at 28 sites in 5 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Immune Thrombocytopenia, Blood Platelet Disorder, Hematologic Diseases
What is being tested?: HMPL-523
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 28 sitesin 5 countries
Study dates: 2 Apr 2024to Nov 2026
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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
Clinically serious hemorrhage requiring immediate adjustment of platelets
Known history of vital organ transplantation or hematopoietic stem-cell transplantation or chimeric antigen receptor T-cells (CAR-T) therapy
Splenectomy within 12 weeks prior to enrollment
Presence of active malignancy unless deemed cured by adequate treatment.

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History of serious cardiovascular disease corrected QT interval (QTcF) ≥450 ms
Uncontrolled hypertension
Being unsuitable to participate in this study as considered by investigators

Trial locations and contacts

28 sites in 5 countries.

Country

City, postcode or hospital

28 sites in 5 countries

United States10 sites

Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Massachusetts General Hospital
Boston, Massachusetts, 02114
Taussig Cancer Institute
Cleveland, Ohio, 44106
San Juan Oncology Associates
Farmington, New Mexico, 87401
Georgetown University Medical Center - Georgetown Lombardi Comprehensive Cancer Center
Georgetown, Delaware, 20007
East Carolina University, Brody School of Medicine
Greenville, North Carolina, 27834
Childrens Hospital of California
Irvine, California, 92868
Texas Oncology San Antonio Medical Center
San Antonio, Texas, 78240
University of Washington (UW) Medical Center
Seattle, Washington, 98195
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, 74146

Other trials in United States

Spain8 sites

Hospital del Mar Barcelona
Barcelona, 08003
Hospital Universitari Vall d'Hebron
Barcelona
University de Burgos
Burgos, 09001
Hospital Gregorio Maranon Madrid
Madrid, 28007
Clinica Universidad de Navarra
Madrid, 28027
Hospital Infanta Leonor
Madrid, 28031
Fundacion Jimenez Diaz
Madrid, 28040
Hospital Morales Meseguer
Murcia, 30008

Other trials in Spain

Australia4 sites

Royal Adelaide Hospital
Adelaide
Canberra Hospital
Canberra
Peninsula Private Hospital
Frankston, Victoria
The Perth Blood Institute (PBI) Hollywood Specialist Centre
West Perth, Western Australia

Other trials in Australia

Germany4 sites

Charite university
Berlin, 10117
Marien Hospital Dusseldorf
Düsseldorf, 40479
UMG Gottingen Hämatologie
Göttingen
University Hospital of Schleswig-Holstein, Department of Haematology and Oncology
Lübeck

Other trials in Germany

Norway2 sites

Sykehuset Ostfold Kalnes (fosta) / Osfold Hospital Trust (MSL)
Grålum, 1714
Oslo University Hospital
Oslo

Other trials in Norway

About this study

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

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

Read the detailed 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.

Conditions: Immune Thrombocytopenia, Blood Platelet Disorder, Hematologic Diseases, Purpura, Thrombocytopenic, Purpura, Blood Coagulation Disorder
Being tested: HMPL-523
Keywords: ITP, sovleplenib
Medical subject headings: Purpura, Thrombocytopenic, Idiopathic, Blood Platelet Disorders, Hematologic Diseases, Purpura, Thrombocytopenic, Purpura, Blood Coagulation Disorders, Thrombotic Microangiopathies, Hemorrhagic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HMPL-523Drug
Also called sovleplenib
Syk inhibitor

Study groups in NCT06291415
Study group	Role	What they receive
Dose escalation	Experimental	Part 1 will consist of the following 3 dose levels: 300, 400, and 500 mg once daily (QD). Receives: Drug: HMPL-523
Dose optimization stage	Experimental	In part 2 subjects will be randomized in a 1:1 ratio between the 2 dose levels selected at the end of part 1. Receives: Drug: HMPL-523

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: week 1 - week 24
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.
Measured: week 1 - week 4

Secondary outcomes (4)

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
Measured: week 1 and week 3
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
Measured: week 1 and week 3
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
Measured: week 1 and week 3
Cmin (minimum plasma drug concentration)
Blood samples will be obtained from all patients to determine minimum plasma concentration of HMPL-523 and metabolite M1
Measured: week 1 - week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 2024Nov 2026

First posted4 Mar 2024
Study start2 Apr 2024
Primary completionApr 2026 (estimated)
Study completionNov 2026 (estimated)

Why it stopped: Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Part 1: Dose escalation stage - 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) Part 2: subjects will be randomized in a 1:1 ratio between the 2 dose levels recommended by the SRC to better understand the exposure/efficacy/toxicity relationship. At the end of Part 2, the SRC will evaluate the safety, tolerability, preliminary efficacy, and PK data to determine the Recommended Phase 3 dose (RP3D) of HMPL-523.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06291415
Sponsor's protocol ID: 2022-523-GLOB1
Status last verified: Sep 2025
First submitted: 13 Feb 2024
Last updated: 16 Sep 2025
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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