protocolSection identificationModule nctId: NCT06378593, orgStudyIdInfo id: 3HP-2827-102, briefTitle: A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: 3H (Suzhou) Pharmaceuticals Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations., conditionsModule conditions: Solid Tumors With FGFR2 Alterations, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: 3HP-2827, outcomesModule primaryOutcomes measure: Dose Escalation Stage- incidence of adverse events (AEs), primaryOutcomes measure: Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs), primaryOutcomes measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs, primaryOutcomes measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results, primaryOutcomes measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters, primaryOutcomes measure: Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827, primaryOutcomes measure: Expansion stage -Objective response rate（ORR）, secondaryOutcomes measure: Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy., secondaryOutcomes measure: Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy., secondaryOutcomes measure: Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy., secondaryOutcomes measure: Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy., secondaryOutcomes measure: Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy., secondaryOutcomes measure: Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy., secondaryOutcomes measure: Duration of Response (DOR) as assessed by RECIST v1.1, secondaryOutcomes measure: Disease control rate (DCR) as assessed by RECIST v1.1, secondaryOutcomes measure: Progression-free survival (PFS) as assessed by RECIST v1.1, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Dose escalation stage - Objective Response Rate (ORR), secondaryOutcomes measure: Expansion Stage- incidence of adverse events (AEs), secondaryOutcomes measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs, secondaryOutcomes measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results, secondaryOutcomes measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters, secondaryOutcomes measure: Expansion Stage -Changes in patient-reported outcomes as assessed by the European Organization for Research and Treatment of Cancer Core QoL Questionnaire (EORTC QLQ-C30) in patients with advanced solid tumors, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Lin Shen, MD, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: ZhongShan Hospital, city: Shanghai, state: Shanghai, zip: 200123, country: China, contacts name: Jia Fan, MD, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False