Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-01-24 @ 7:38 AM
Study NCT ID:
NCT06381050
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2024-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Study of SHR-7631 for Injection in Patients With Advanced 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': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2024-04-19', 'studyFirstSubmitQcDate': '2024-04-19', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) or maximum administered dose (MAD)', 'timeFrame': '12 months'}, {'measure': 'Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0)', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'PK parameter: Tmax', 'timeFrame': '36 months'}, {'measure': 'PK parameter: Cmax', 'timeFrame': '36 months'}, {'measure': 'PK parameter: AUC0-t', 'timeFrame': '36 months'}, {'measure': 'PK parameter: AUC0-∞', 'timeFrame': '36 months'}, {'measure': 'PK parameter: t1/2', 'timeFrame': '36 months'}, {'measure': 'PK parameter: MRT (mean residence time)', 'timeFrame': '36 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This study is an open-label, phase I clinical trial of SHR-7631 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;\n2. Have at least one measurable tumor lesion per RECIST v1.1 (subject with only non-target tumor lesion will be permitted if he/she is planned to participant in dose escalation stage or with mCRPC);\n3. ECOG performance status of 0-1;\n4. Life expectancy ≥ 12 weeks;\n5. Adequate bone marrow and organ function\n6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.\n7. Age 18 to 75 years old (including both ends), gender is not limited;\n\nExclusion Criteria:\n\n1. Patients with active central nervous system metastases or meningeal metastases;\n2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;\n3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;\n4. History of serious cardiovascular and cerebrovascular diseases;\n5. Severe infection within 4 weeks prior to the first dose;\n6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.'}, 'identificationModule': {'nctId': 'NCT06381050', 'briefTitle': 'The Clinical Study of SHR-7631 for Injection in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7631 for Injection in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'SHR-7631-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-7631', 'interventionNames': ['Drug: SHR-7631']}], 'interventions': [{'name': 'SHR-7631', 'type': 'DRUG', 'description': 'The total dosage of SHR-7631 was calculated according to the weight weighing results of the subjects before each administration, and was administered by intravenous drip.', 'armGroupLabels': ['SHR-7631']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510062', 'city': 'Guangzhou', 'state': 'Guangzhou', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}