Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 7:08 AM
Study NCT ID:
NCT04974957
Status:
UNKNOWN
Last Update Posted:
2021-07-23
First Post:
2021-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 71}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-16', 'studyFirstSubmitDate': '2021-07-16', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': '2 years'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': '2 years'}, {'measure': 'Duration of response (DOR)', 'timeFrame': '2 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study was to assess the safety,efficacy and pharmacokinetic when combining SHR-1701 and BP102 in participants with advanced or metastatic non-squamous non-small cell lung cancer. To explore the immunogenicity of SHR-1701 and the relationship between corresponding biomarkers and therapeutic effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.\n2. Failed with prior systemic treatments.\n3. Measurable disease, as defined by RECIST v1.1\n4. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1\n5. Life expectancy ≥ 3 months\n6. Adequate hematologic and end-organ function as defined in the protocol\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed mixed SCLC and NSCLC.\n2. Symptomatic, untreated or active central nervous system metastases.\n3. Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment\n4. With any active autoimmune disease or history of autoimmune disease.\n5. Inadequately controlled hypertension.\n6. Tumor infiltration into the great vessels on imaging.\n7. History of hemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.\n8. Uncontrolled tumor-related pain.\n9. Patients with active hepatitis B or hepatitis C\n10. Severe infections within 4 weeks prior to initiation of study treatment.\n11. Active tuberculosis within one year prior to initiation of study treatment.'}, 'identificationModule': {'nctId': 'NCT04974957', 'briefTitle': 'Study of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors', 'orgStudyIdInfo': {'id': 'SHR-1701-II-207-LC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1701+BP102', 'interventionNames': ['Drug: SHR-1701；BP102']}], 'interventions': [{'name': 'SHR-1701；BP102', 'type': 'DRUG', 'description': 'Drug: SHR-1701 IV infusion\n\nDrug: BP102 IV infusion', 'armGroupLabels': ['SHR-1701+BP102']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hao Shen', 'role': 'CONTACT', 'email': 'hao.shen@hengrui.com', 'phone': '+0518-82342973'}, {'name': 'You Li', 'role': 'CONTACT', 'email': 'you.li.yl1@hengrui.com', 'phone': '13408501487'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}