Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-04 @ 8:37 AM
Study NCT ID:
NCT06727812
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Phase I Study of HRS-6208 in Patients With Solid Tumors
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': 'ESTIMATED', 'count': 206}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2024-12-06', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': 'From Day 1 to 30 days after the last dose.'}, {'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'From Day 1 to 21 days after the first dose.'}, {'measure': 'Dose limiting toxicity (DLT)', 'timeFrame': 'From Day 1 to 21 days after the first dose.'}, {'measure': 'Recommended phase 2 dose (RP2D)', 'timeFrame': 'From Day 1 to 30 days after the last dose.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).'}, {'measure': 'Progression free Survival (PFS)', 'timeFrame': 'From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is an open, multicenter Phase I study to evaluate the safety and tolerability of HRS-6208 in patients with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology who have relapsed or progressed after standard treatment, or have no standard treatment options, or do not apply standard treatment at this stage;\n2. Age 18\\~75 years old;\n3. At least one measurable lesion per RECIST v1.1 criteria;\n4. ECOG PS score: 0-1.\n\nExclusion Criteria:\n\n1. History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;\n2. The adverse reactions of previous anti-tumor therapy have not recovered to NCI-CTCAE v5.0 grade evaluation ≤ 1;\n3. He has severe cardiovascular and cerebrovascular diseases;\n4. Severe infection within 4 weeks prior to the first dose.'}, 'identificationModule': {'nctId': 'NCT06727812', 'briefTitle': 'Multicenter Phase I Study of HRS-6208 in Patients With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Suncadia Medicine Co., Ltd.'}, 'officialTitle': 'A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HRS-6208 Monotherapy in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'HRS-6208-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'interventionNames': ['Drug: HRS-6208']}], 'interventions': [{'name': 'HRS-6208', 'type': 'DRUG', 'description': 'HRS-6208.', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongqian Guo', 'role': 'CONTACT', 'email': 'gymwpi@126.com', 'phone': '+86-025-83106666'}, {'name': 'Hongqian Guo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping Feng', 'role': 'CONTACT', 'email': '617130961@qq.com', 'phone': '028-85423583'}, {'name': 'Ting Luo', 'role': 'CONTACT', 'email': 'luoting@wchscu.cn', 'phone': '028-85423583'}, {'name': 'Ping Feng', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ting Luo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Xin Xu', 'role': 'CONTACT', 'email': 'xin.xu@hengrui.com', 'phone': '0518-82342973'}, {'name': 'Zhiye Chen', 'role': 'CONTACT', 'email': 'zhiye.chen.zc78@hengrui.com', 'phone': '0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}