Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-01-01 @ 2:28 AM
Study NCT ID:
NCT06895928
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2025-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'C000596361', 'term': 'osimertinib'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (AEs)', 'timeFrame': 'From day 1 to 90 days after the last dose.'}, {'measure': 'Serious adverse events (SAEs)', 'timeFrame': 'From day 1 to 90 days after the last dose.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'About 2 years.'}], 'secondaryOutcomes': [{'measure': 'Disease control rate (DCR)', 'timeFrame': 'About 2 years.'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'About 2 years.'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'About 2 years.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'About 2 years.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with other antitumor therapies in advanced solid tumors to explore the reasonable dosage, safety and efficacy of SHR-A2102 for advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The age of signing the informed consent is 18 -70 years, regardless of gender.\n2. At least one measurable lesion according to RECIST v1.1 criteria.\n3. The ECOG score is 0 or 1.\n4. Expected survival ≥12 weeks.\n5. Good level of organ function.\n6. Have the ability to give informed consent and to comply with the treatment plan.\n7. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.\n\nExclusion Criteria:\n\n1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases.\n2. Spinal cord compression not cured by surgery and/or radiotherapy.\n3. Subjects with uncontrolled tumor-related pain.\n4. Received antitumor therapy within 4 weeks before the start of the study.\n5. Subjects with severe cardiovascular and cerebrovascular disease.\n6. History of immunodeficiency, including a positive HIV test.'}, 'identificationModule': {'nctId': 'NCT06895928', 'briefTitle': 'A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hengrui Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'SHR-A2102-209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'interventionNames': ['Drug: SHR-A2102', 'Drug: Bevacizumab Injection', 'Drug: Adebelimab Injection', 'Drug: Ametinib Mesylate Tablets', 'Drug: Osimertinib Mesylate Tablets']}], 'interventions': [{'name': 'SHR-A2102', 'type': 'DRUG', 'description': 'SHR-A2102 for injection.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Bevacizumab Injection', 'type': 'DRUG', 'description': 'Bevacizumab injection.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Adebelimab Injection', 'type': 'DRUG', 'description': 'Adebelimab injection.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Ametinib Mesylate Tablets', 'type': 'DRUG', 'description': 'Ametinib mesylate tablets.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Osimertinib Mesylate Tablets', 'type': 'DRUG', 'description': 'Osimertinib mesylate tablets.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '030001', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Wang', 'role': 'CONTACT', 'email': 'zlhuxi@163.com', 'phone': '+86-0351-4881611'}, {'name': 'Jie Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanxi Cancer hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'centralContacts': [{'name': 'Yang Wu', 'role': 'CONTACT', 'email': 'yang.wu.yw96@hengrui.com', 'phone': '+86-0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}