Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 6:41 AM
Study NCT ID:
NCT06378593
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2024-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Escalation Stage- incidence of adverse events (AEs)', 'timeFrame': 'From baseline up until 28 days after the final dose'}, {'measure': 'Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs)', 'timeFrame': 'Days 1-28 of Cycle 1 (a cycle is 28 days)'}, {'measure': 'Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs', 'timeFrame': 'From baseline up until 28 days after the final dose'}, {'measure': 'Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results', 'timeFrame': 'From baseline up until 28 days after the final dose'}, {'measure': 'Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters', 'timeFrame': 'From baseline up until 28 days after the final dose'}, {'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', 'timeFrame': 'Initiation of study drug until study discontinuation, (up to approximately 24 months)'}, {'measure': 'Expansion stage -Objective response rate（ORR）', 'timeFrame': 'Initiation of study drug until disease progression (up to approximately 36 months)', 'description': 'ORR refers to the percentage of patients with best overall response of confirmed CR or PR from the start of study treatment to patient withdrawal due to PD.'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy.', 'timeFrame': 'Initiation of study drug until study discontinuation, (up to approximately 24 months))'}, {'measure': 'Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy.', 'timeFrame': 'Initiation of study drug until study discontinuation, (up to approximately 24 months))'}, {'measure': 'Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy.', 'timeFrame': 'Initiation of study drug until study discontinuation, (up to approximately 24 months))'}, {'measure': 'Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy.', 'timeFrame': 'Initiation of study drug until study discontinuation, (up to approximately 24 months))'}, {'measure': 'Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy.', 'timeFrame': 'Initiation of study drug until study discontinuation, (up to approximately 24 months))'}, {'measure': 'Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy.', 'timeFrame': 'Initiation of study drug until study discontinuation, (up to approximately 24 months))'}, {'measure': 'Duration of Response (DOR) as assessed by RECIST v1.1', 'timeFrame': 'Up to 45 months', 'description': 'DOR refers to the time period from the first evaluation of confirmed CR or PR (whichever occurs first) to PD or death.'}, {'measure': 'Disease control rate (DCR) as assessed by RECIST v1.1', 'timeFrame': 'Up to 45 months', 'description': 'DCR refers to the percentage of patients with best overall response of confirmed CR, PR or SD from the start of study treatment to patient withdrawal due to PD.'}, {'measure': 'Progression-free survival (PFS) as assessed by RECIST v1.1', 'timeFrame': 'Up to 45 months', 'description': "PFS refers to the time between the date of first dose and the first PD or death due to any cause based on the investigator's imaging review results"}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 48 months', 'description': 'OS refers to the time from the date of first dose to the date of death due to any cause.'}, {'measure': 'Dose escalation stage - Objective Response Rate (ORR)', 'timeFrame': 'Up to 45 months', 'description': 'ORR refers to the percentage of patients with best overall response of confirmed CR or PR from the start of study treatment to patient withdrawal due to PD.'}, {'measure': 'Expansion Stage- incidence of adverse events (AEs)', 'timeFrame': 'From baseline up until 28 days after the final dose'}, {'measure': 'Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs', 'timeFrame': 'From baseline up until 28 days after the final dose'}, {'measure': 'Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results', 'timeFrame': 'From baseline up until 28 days after the final dose'}, {'measure': 'Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters', 'timeFrame': 'From baseline up until 28 days after the final dose'}, {'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', 'timeFrame': 'From baseline up until 28 days after the final dose'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumors With FGFR2 Alterations, Adult']}, '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is willing and able to provide written informed consent and has the ability to comply with the study protocol\n* Men or women, age ≥ 18 years at the time of signing informed consent.\n* Histologically or cytologically confirmed surgically unresectable, locally advanced, metastatic solid tumor.\n* ECOG score is 0 or 1.\n* An expected survival of ≥ 12 weeks.\n* Evaluable or measurable disease per RECIST v1.1.\n* Adequate organ function, as measured by laboratory values.\n\nExclusion Criteria:\n\n* Active brain metastases.\n* Have other malignancies within the past 3 years.\n* The toxicity from previous anti-tumor treatment has not recovered to ≤ grade 1.\n* Clinically significant corneal or retinal disease/keratopathy.\n* Clinically significant cardiovascular disorders.\n* Failure to swallow, chronic diarrhea, or presence of other factors affecting drug absorption.\n* Known to be allergic to any study drug or any of its excipients.\n* Assessed by the investigator to be unsuitable for participation in this study.'}, 'identificationModule': {'nctId': 'NCT06378593', 'briefTitle': 'A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations', 'organization': {'class': 'INDUSTRY', 'fullName': '3H (Suzhou) Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'An Open-Label, Multi-center Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Activity of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations', 'orgStudyIdInfo': {'id': '3HP-2827-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage I - dose escalation', 'description': 'Dose escalation of 3HP-2827 in patients with advanced solid tumors.', 'interventionNames': ['Drug: 3HP-2827']}, {'type': 'EXPERIMENTAL', 'label': 'Stage II - expansion', 'description': 'Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I.', 'interventionNames': ['Drug: 3HP-2827']}], 'interventions': [{'name': '3HP-2827', 'type': 'DRUG', 'description': '3HP-2827 will be administered orally once daily in 28-day cycles.', 'armGroupLabels': ['Stage I - dose escalation', 'Stage II - expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Shen, MD', 'role': 'CONTACT'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200123', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jia Fan, MD', 'role': 'CONTACT'}], 'facility': 'ZhongShan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shuchao Wu', 'role': 'CONTACT', 'email': 'shuchao.wu@3hpharma.com', 'phone': '+86-21-50895559'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '3H (Suzhou) Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}