Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT06287918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-29
First Post:
2024-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', '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)'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentration of 3HP-2827 and/or its major metabolites', 'timeFrame': 'Initiation of study drug until study discontinuation（up to 45 months）'}, {'measure': 'Duration of Response (DOR) as assessed by RECIST v1.1', 'timeFrame': 'Up to 45 months'}, {'measure': 'Progression-free survival (PFS) as assessed by RECIST v1.1', 'timeFrame': 'Up to 45 months'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 48 months'}, {'measure': 'Dose escalation stage - Objective Response Rate (ORR)', 'timeFrame': 'Up to 45 months'}, {'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'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, '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. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).'}, '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* Any other diseases or clinical laboratory, etc that may affect the interpretation of the results, or renders the patients at high risk from treatment complications.'}, 'identificationModule': {'nctId': 'NCT06287918', 'briefTitle': 'A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations', 'organization': {'class': 'INDUSTRY', 'fullName': '3H (Suzhou) Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'A First-in-human, Open-label, Dose Escalation and Expansion 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-2827-101'}}, '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': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], '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'}}}}