nctId: NCT06378593 id: 3HP-2827-102 briefTitle: A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-03 date: 2028-06 date: 2024-04-22 date: 2024-04-22 name: 3H (Suzhou) Pharmaceuticals Co., Ltd. class: INDUSTRY 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. conditions: Solid Tumors With FGFR2 Alterations, Adult studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: 3HP-2827 measure: Dose Escalation Stage- incidence of adverse events (AEs) measure: Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs) measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters 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 measure: Expansion stage -Objective response rate（ORR） measure: Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy. measure: Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Duration of Response (DOR) as assessed by RECIST v1.1 measure: Disease control rate (DCR) as assessed by RECIST v1.1 measure: Progression-free survival (PFS) as assessed by RECIST v1.1 measure: Overall survival (OS) measure: Dose escalation stage - Objective Response Rate (ORR) measure: Expansion Stage- incidence of adverse events (AEs) measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters 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 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Lin Shen, MD role: CONTACT lat: 39.9075 lon: 116.39723 facility: ZhongShan Hospital city: Shanghai state: Shanghai zip: 200123 country: China name: Jia Fan, MD role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False