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

2022-523-GLOB1

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

2024-04-02

2026-04-01

2026-11-01

Recruiting

Early phase I

48

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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)\n\nPart 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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}

2024-04-19