Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-04 @ 3:35 AM
Study NCT ID:
NCT05010694
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2021-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GH35 Tablets for Advanced Solid Tumors: A Study on Safety and Early Results
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2021-08-11', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicities (DLT)', 'timeFrame': '24 Days', 'description': 'Number of participants with dose limiting toxicities (DLTs)'}], 'secondaryOutcomes': [{'measure': 'Characterize the safety of GH35 in subjects', 'timeFrame': '30 Months', 'description': 'Number of participants with treatment-emergent adverse events'}, {'measure': 'Pharmacokinetics of GH35', 'timeFrame': '1 Month', 'description': 'Blood plasma concentration'}, {'measure': 'Objective response rate (ORR) as defined by RECIST 1.1 criteria', 'timeFrame': '30 Months'}, {'measure': 'Duration of response (DOR) as defined by RECIST 1.1 criteria', 'timeFrame': '30 Months'}, {'measure': 'Progression-free survival (PFS) as defined by RECIST 1.1 criteria', 'timeFrame': '30 Months'}, {'measure': 'Disease control rate (DCR) as defined by RECIST 1.1 criteria', 'timeFrame': '30 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Solid Tumors, KRAS'], 'conditions': ['Advanced Solid Tumors Harboring With G12C Mutation']}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and tolerability of GH35 in patients with KRAS mutant advanced solid tumors.\n\nEstimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects greater than or equal to 18 years old.\n2. Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.\n3. Expected survival time ≥12 weeks.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.\n6. Have documented disease progression or intolerance after first-line treatment.\n\nExclusion Criteria:\n\n1. Gastrointestinal (GI) tract disease causing the inability to take oral medication.\n2. Previous accept with KRAS G12C inhibitor.\n3. Uncontrollable general infection.\n4. Serious cardiovascular disease.\n5. Left ventricular ejection fraction (LVEF) \\<50 %.\n6. Known history of hypersensitivity to any of the excipients of GH35 tablets\n7. Pregnant or nursing (lactating) women.'}, 'identificationModule': {'nctId': 'NCT05010694', 'briefTitle': 'GH35 Tablets for Advanced Solid Tumors: A Study on Safety and Early Results', 'organization': {'class': 'OTHER', 'fullName': 'Suzhou Genhouse Bio Co., Ltd.'}, 'officialTitle': 'A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH35 Tablets in Patients Harboring With G12C Mutation in Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'GH35-CRS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monotherapy Dose Escalation.', 'description': 'Treatment with GH35 alone, conducted until disease progression, intolerance or end of study.', 'interventionNames': ['Drug: GH35 Tablet']}], 'interventions': [{'name': 'GH35 Tablet', 'type': 'DRUG', 'description': 'GH35 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.', 'armGroupLabels': ['Monotherapy Dose Escalation.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Baohui Han, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Genhouse Bio Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}