Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT07262567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005641', 'term': 'Tegafur'}, {'id': 'C104201', 'term': 'gimeracil'}, {'id': 'C489337', 'term': 'potassium oxonate'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Experimental group: GFH375; Control group: investigator's choice of Chemotherapy"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OS', 'timeFrame': 'Up to approximately 2 years', 'description': 'Overall Survival'}, {'measure': 'PFS', 'timeFrame': 'Up to approximately 2 years', 'description': 'Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by BICR'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'Up to approximately 2 years', 'description': 'Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors'}, {'measure': 'ORR', 'timeFrame': 'Up to approximately 2 years', 'description': 'ORR assessed by investigators and BICR'}, {'measure': 'DCR', 'timeFrame': 'Up to approximately 2 years', 'description': 'DCRassessed by investigators and BICR'}, {'measure': 'DoR', 'timeFrame': 'Up to approximately 2 years', 'description': 'DoR assessed by investigators and BICR'}, {'measure': 'TTR', 'timeFrame': 'Up to approximately 2 years', 'description': 'TTR assessed by investigators and BICR'}, {'measure': 'The incidence and severity of AEs and SAEs', 'timeFrame': 'Up to approximately 2 years', 'description': 'The incidence and severity of AEs and SAEs'}, {'measure': 'EORTC QLQ-C30 Score', 'timeFrame': 'Up to approximately 2 years', 'description': 'Changes in EORTC QLQ-C30'}, {'measure': 'EORTC QLQ-PAN26 Score', 'timeFrame': 'Up to approximately 2 years', 'description': 'Changes in EORTC QLQ-PAN26 Scores'}, {'measure': 'Plasma concentrations of GFH375', 'timeFrame': 'Up to approximately 2 years', 'description': 'Plasma concentrations of GFH375'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily participate in the study and sign the informed consent form.\n* Male or female aged 18-80 years (inclusive) at the time of signing the informed consent form.\n* Pathologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) at metastatic stage.\n* Have received at least one prior standard systemic therapy.\n* Participants must have at least one measurable lesion (per RECIST 1.1 criteria).\n* Expected survival time ≥ 12 weeks as judged by the investigator.\n* Have adequate organ function\n\nExclusion Criteria:\n\n* Other malignant tumors that progressed or required treatment within 3 years prior to randomization.\n* With active central nervous system (CNS) metastasis.\n* Previous receipt of therapy targeted for KRAS G12D or pan-RAS/KRAS.\n* Received radiotherapy within 4 weeks prior to randomization or other local anti-tumor therapy within 4 weeks prior to randomization.\n* Received other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to randomization.\n* With clinically significant severe cardiovascular diseases.\n* Stroke or other severe cerebrovascular diseases within 6 months prior to randomization.\n* Complicated with major acute or chronic infectious diseases.\n* Have severe mental or psychological diseases, or a history of drug abuse or severe alcoholism.\n* Pregnant or lactating females.\n* Other conditions deemed inappropriate for participation in the study by the investigator.'}, 'identificationModule': {'nctId': 'NCT07262567', 'briefTitle': 'Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genfleet Therapeutics (Shanghai) Inc.'}, 'officialTitle': "A Multicenter, Open-Label, Randomized Controlled Phase III Study to Compare the Efficacy and Safety/Tolerability of GFH375 Monotherapy Versus Investigator's Choice of Chemotherapy in Patients With Previously Treated KRAS G12D-Mutant Metastatic Pancreatic Cancer", 'orgStudyIdInfo': {'id': 'GFH375X1301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GFH375', 'description': 'GFH375, Oral tablets', 'interventionNames': ['Drug: GFH375']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy', 'description': 'There are three chemotherapy regimens. If participants are randomized to the control group, they will receive the treatment as determined by the investigator.', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'GFH375', 'type': 'DRUG', 'description': 'The experimental group receives GFH375 monotherapy, QD, orally', 'armGroupLabels': ['GFH375']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'otherNames': ['Irinotecan Hydrochloride Liposome Injection', 'Fluorouracil Injection', 'Calcium Folinate', 'Tegafur,Gimeracil and Oteracil Potassium Capsules', 'Gemcitabine Hydrochloride for Injection', 'Paclitaxel for Injection(Albumin Bound)'], 'description': 'The control group includes three treatment regimens: AG, nal-IRI + 5-FU/LV, and S-1. If participants are randomized to the control group, they will receive the treatment which is determined by the investigator.', 'armGroupLabels': ['Chemotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jin Li', 'role': 'CONTACT', 'email': 'jli@genfleet.com', 'phone': '+86 21 6882 1388'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genfleet Therapeutics (Shanghai) Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}