protocolSection identificationModule nctId: NCT06387082, orgStudyIdInfo id: 2023-506-00CH1, briefTitle: A Clinical Study of HMPL-506 in Patients With Hematological Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-09, primaryCompletionDateStruct date: 2027-10-08, completionDateStruct date: 2027-12-08, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Hutchmed, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, multicenter, open-label clinical study of HMPL-506 administered orally in the treatment of hematological malignancies. Only eligible patients who provide the signed informed consent form (ICF) can be enrolled in this study. The study consists of two phases, i.e., a dose escalation phase and a dose expansion phase. The study is expected to enroll approximately 60 to 98 patients, including approximately 30 to 38 patients in the dose escalation phase and approximately 30 to 60 patients in the dose expansion phase., conditionsModule conditions: Hematological Malignancies, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 98, type: ESTIMATED, armsInterventionsModule interventions name: HMPL-506, outcomesModule primaryOutcomes measure: Safety evaluation: Safety Incidence of Dose-limiting Toxicity (DLTs), primaryOutcomes measure: Safety evaluation: Incidence of serious adverse events (SAEs) and Relationship to Study Drug, primaryOutcomes measure: Efficacy evaluation: Anti-tumor efficacy evaluation., secondaryOutcomes measure: Incidence of adverse events (AEs) and Relationship to Study Drug, secondaryOutcomes measure: Adverse Events Associated with Dose Modifications, secondaryOutcomes measure: Evaluate electrocardiogram (ECG) assessments., secondaryOutcomes measure: Complete response rate (CR rate), secondaryOutcomes measure: Complete response (CR)+ Complete response with partial recovery of hematology (CRh) rate, secondaryOutcomes measure: Composite complete response (CRc) rate, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Time to Complete response (CR)+Complete response with partial recovery of hematology (CRh), secondaryOutcomes measure: Time to Complete response (CR)+Complete response with partial recovery of hematology (CRh) +incomplete hematological recovery (CRi), secondaryOutcomes measure: Time to disease response (TTR), secondaryOutcomes measure: Duration of Complete response (CR)+Complete response with partial recovery of hematology (CRh), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Relapse-free survival (RFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Pharmacokinetic analysis-Maximum concentration (Cmax), secondaryOutcomes measure: Pharmacokinetic analysis: Peak time (Tmax), secondaryOutcomes measure: Pharmacokinetic analysis: Clearance half-life (T1/2), secondaryOutcomes measure: Pharmacokinetic analysis: area under the plasma concentration-time curve (AUC0-t), otherOutcomes measure: Evaluate the changes of the Pharmacodynamic Biomarker, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False