protocolSection identificationModule nctId: NCT06287918, orgStudyIdInfo id: 3HP-2827-101, briefTitle: A First-in-human Study of 3HP-2827 in Patients With 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: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-11, 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. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II)., conditionsModule conditions: Solid Tumors With FGFR2 Alterations, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, 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: Plasma Concentration of 3HP-2827 and/or its major metabolites, secondaryOutcomes measure: Duration of Response (DOR) as assessed by RECIST v1.1, secondaryOutcomes measure: Progression-free survival (PFS) as assessed by RECIST v1.1, secondaryOutcomes measure: Overall survival, 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, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Phoenix, state: Arizona, zip: 85054, country: United States, geoPoint lat: 33.44838, lon: -112.07404, locations facility: The University of Texas MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False