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

PHASE1RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion 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

Exclusion criteria

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.

History of serious cardiovascular disease corrected QT interval (QTcF) ≥450 ms

Uncontrolled hypertension

Being unsuitable to participate in this study as considered by investigators

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-04-02

Primary completion: 2026-04-01

Study completion finish: 2026-11-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06291415

Intervention or treatment

DRUG: HMPL-523

Conditions

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

Condition: Autoimmune Diseases, Primary Immune Thrombocytopenia and more
DRUG: HMPL-523
Adelaide, Not Specified, Australia and more
Sponsor: Hutchmed

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, Not Specified, Australia
Peninsula Private Hospital
Frankston, Victoria, Australia
The Perth Blood Institute (PBI) Hollywood Specialist Centre
West Perth, Western Australia, Australia
Canberra Hospital
Canberra, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dose escalation Part 1 will consist of the following 3 dose levels: 300, 400, and 500 mg once daily (QD).	DRUG: HMPL-523 Syk inhibitor
EXPERIMENTAL: Dose optimization stage In part 2 subjects will be randomized in a 1:1 ratio between the 2 dose levels selected at the end of part 1.	DRUG: HMPL-523 Syk inhibitor

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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
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
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
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

Frequently Asked Questions

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References

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