protocolSection identificationModule nctId: NCT06291415, orgStudyIdInfo id: 2022-523-GLOB1, briefTitle: The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hutchmed, class: INDUSTRY, descriptionModule briefSummary: This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP., conditionsModule conditions: Immune Thrombocytopenia, conditions: Blood Platelet Disorder, conditions: Hematologic Diseases, conditions: Purpura, Thrombocytopenic, conditions: Purpura, conditions: Blood Coagulation Disorder, conditions: Thrombotic Microangiopathies, conditions: Hemorrhagic Disorders, conditions: Autoimmune Diseases, conditions: Immune System Diseases, conditions: Hemorrhage, conditions: Pathologic Processes, conditions: Skin Manifestations, conditions: Thrombocytopenia, conditions: Purpura, Thrombocytopenic, Idiopathic, conditions: Primary Immune Thrombocytopenia, conditions: ITP - Immune Thrombocytopenia, designModule 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)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., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: HMPL-523, outcomesModule primaryOutcomes measure: Safety and tolerability of HMPL-523 in adult subjects with primary ITP, primaryOutcomes measure: Dose Limiting Toxicities, secondaryOutcomes measure: Cmax (maximum plasma drug concentration), secondaryOutcomes measure: AUCtau (area under the concentration-time curve over a dosage interval), secondaryOutcomes measure: Tmax (time to reach maximum plasma drug concentration), secondaryOutcomes measure: Cmin (minimum plasma drug concentration), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Cancer and Blood Disorders, status: RECRUITING, city: Bethesda, state: Maryland, zip: 20817, country: United States, contacts name: Ralph V Boccia, MD, role: CONTACT, contacts name: Ralph V Boccia, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.98067, lon: -77.10026, locations facility: Massachusetts General Hospital, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: David J Kuter, MD, role: CONTACT, contacts name: David J Kuter, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Taussig Cancer Institute, status: NOT_YET_RECRUITING, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Alan Lichtin, MD, role: CONTACT, contacts name: Alan Lichtin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Peninsula Private Hospital, status: NOT_YET_RECRUITING, city: Frankston, state: Victoria, country: Australia, contacts name: Huy Tran, MD, role: CONTACT, contacts name: Huy Tran, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -38.14458, lon: 145.12291, locations facility: The Perth Blood Institute (PBI) Hollywood Specialist Centre, status: NOT_YET_RECRUITING, city: West Perth, state: Western Australia, country: Australia, contacts name: Ross Baker, MD, role: CONTACT, contacts name: Ross Baker, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.94896, lon: 115.84199, locations facility: Marien Hospital Dusseldorf, status: NOT_YET_RECRUITING, city: Düsseldorf, zip: 40479, country: Germany, contacts name: Stefanie Groepper, MD, role: CONTACT, contacts name: Stefanie Groepper, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.22172, lon: 6.77616, locations facility: Sykehuset Ostfold Kalnes (fosta) / Osfold Hospital Trust (MSL), status: NOT_YET_RECRUITING, city: Grålum, zip: 1714, country: Norway, contacts name: Waleed Ghanima, MD, role: CONTACT, contacts name: Waleed Ghanima, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.29048, lon: 11.06668, locations facility: Hospital del Mar Barcelona, status: NOT_YET_RECRUITING, city: Barcelona, zip: 08003, country: Spain, contacts name: Blanca Gonzalez, MD, role: CONTACT, contacts name: Blanca Gonzalez, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitari Vall d'Hebron, status: NOT_YET_RECRUITING, city: Barcelona, country: Spain, contacts name: David Ferreiras, MD, role: CONTACT, contacts name: David Ferreiras, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: University de Burgos, status: NOT_YET_RECRUITING, city: Burgos, zip: 09001, country: Spain, contacts name: Jose Gonzalez Lopez, MD, role: CONTACT, contacts name: Jose Gonzalez Lopez, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.34106, lon: -3.70184, locations facility: Hospital Gregorio Maranon Madrid, status: NOT_YET_RECRUITING, city: Madrid, zip: 28007, country: Spain, contacts name: Cristina Izquierdo, MD, role: CONTACT, contacts name: Cristina Izquierdo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Clinica Universidad de Navarra, status: NOT_YET_RECRUITING, city: Madrid, zip: 28027, country: Spain, contacts name: Carlos Garcia Grande, MD, role: CONTACT, contacts name: Carlos Garcia Grande, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Infanta Leonor, status: NOT_YET_RECRUITING, city: Madrid, zip: 28031, country: Spain, contacts name: Angeles Foncillas, MD, role: CONTACT, contacts name: Angeles Foncillas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Fundacion Jimenez Diaz, status: NOT_YET_RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: Pilar Llamas Sillero, MD, role: CONTACT, contacts name: Pilar Llamas Sillero, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Morales Meseguer, status: NOT_YET_RECRUITING, city: Murcia, zip: 30008, country: Spain, contacts name: Maria Lozano, MD, role: CONTACT, contacts name: Maria Lozano, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98704, lon: -1.13004, hasResults: False