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.
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
- Are there results?
- None posted in the registry
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.
Show all 9Show fewer
- 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.
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
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
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
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
Norway2 sites
Sykehuset Ostfold Kalnes (fosta) / Osfold Hospital Trust (MSL)
Grålum, 1714
Oslo University Hospital
Oslo
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 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.
- 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.
- More trials run by HutchmedThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Schelman, MD, PhD, Study director, Hutchmed
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06291415
- Acronym / sponsor ID
- 2022-523-GLOB1
- Conditions
- Immune Thrombocytopenia, Blood Platelet Disorder, Hematologic Diseases, Purpura, Thrombocytopenic, Purpura, Blood Coagulation Disorder
- Keywords
- ITP, sovleplenib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: HMPL-523Part 1 will consist of the following 3 dose levels: 300, 400, and 500 mg once daily (QD). |
| Dose optimization stage | Experimental | Drug: HMPL-523In part 2 subjects will be randomized in a 1:1 ratio between the 2 dose levels selected at the end of part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMPL-523Also: sovleplenibSyk inhibitor | Drug | Dose escalation, Dose optimization stage |
Primary outcome
Safety and tolerability of HMPL-523 in adult subjects with primary ITP
Time frame: week 1 - week 24
Calculated as the number and percent incidence of participants experiencing adverse events (AE).
Dose Limiting Toxicities
Time frame: week 1 - week 4
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.
4 secondary outcomes
Cmax (maximum plasma drug concentration)
Time frame: week 1 and week 3
AUCtau (area under the concentration-time curve over a dosage interval)
Time frame: week 1 and week 3
Tmax (time to reach maximum plasma drug concentration)
Time frame: week 1 and week 3
Cmin (minimum plasma drug concentration)
Time frame: week 1 - week 20
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Schelman, MD, PhD study director
Hutchmed
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Spain, Australia, Germany, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of HMPL-523 in adult subjects with primary ITP (time frame: week 1 - week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.