Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-02-26 @ 12:03 PM
Study NCT ID:
NCT01847118
Status:
UNKNOWN
Last Update Posted:
2015-03-24
First Post:
2013-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ia, Dose Escalation Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in Patients With Advanced or Metastatic 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': 31}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-22', 'studyFirstSubmitDate': '2013-04-26', 'studyFirstSubmitQcDate': '2013-05-03', 'lastUpdatePostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'up to 28 days'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'd1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57'}, {'measure': 'tmax', 'timeFrame': 'd1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57'}, {'measure': 'AUC', 'timeFrame': 'd1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57'}, {'measure': 't1/2', 'timeFrame': 'd1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'd29, d86'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'd29, d86'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors', 'Metastatic Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This study is to assess the safety, tolerability and pharmacokinetics of single dose and multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with advanced or metastatic solid tumors. The secondary objective is to explore the preliminary anti-tumor effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced or metastatic malignant solid tumors;\n* Patients failed the standard anti-tumor therapy or don't have standard regimen;\n* At least one measurable lesion;\n* At least 4 weeks from the last chemotherapy, 6 weeks from mitomycin, and nitrosourea treatment. If patients received anti-tumor biological products, at least four t1/2 of washout period is needed;\n* Toxicity from previous treatment has to restore to ≤ grade 1 (NCI CTC4.0);\n* ECOG performance status 0-1;\n* Life expectancy ≥ 3 months;\n* Adequate hematologic function: ANC ≥ 1.5 × 10\\^9 /L, HB ≥ 90 g /L (blood transfusion allowed), PLT ≥ 100 × 10\\^9 /L;\n* Adequate hepatic function: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (patients with liver metastases ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN);\n* Adequate renal function: creatinine ≤ 1 × ULN;\n* Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN;\n* Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 12 weeks after the last dose.\n\nExclusion Criteria:\n\n* HCV, TP or HIV antibody positive;\n* Previously received anti-VEGF protein drugs, such as bevacizumab;\n* Histologically proven squamous cell lung cancer or squamous cell carcinoma of the head and neck;\n* Active hepatitis B infection;\n* Evidence of serious infection;\n* Symptomatic brain metastases;\n* Patients with proteinuria at screening (urine protein ≥ 1+);\n* History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment;\n* Serious non-healing wounds, ulcers or fractures;\n* Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment;\n* Active bleeding within 3 months prior to enrollment;\n* Bleeding diathesis or coagulation disorder;\n* History of arterial or venous thrombosis;\n* History of myocardial infarction or stroke within 6 months prior to enrollment;\n* Unstable angina, congestive heart failure, New York Heart Association (NYHA) class II heart failure, uncontrollable arrhythmia, uncontrolled hypertension (systolic blood pressure\\> 150 mmHg and/or diastolic blood pressure\\> 100 mmHg);\n* Pregnant and lactating women;\n* Known allergies to any excipient in the study drug;\n* Patients with alcohol or drug dependence;\n* Participation in other clinical trials within 4 weeks before enrollment."}, 'identificationModule': {'nctId': 'NCT01847118', 'briefTitle': 'A Phase Ia, Dose Escalation Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in Patients With Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Simcere Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase Ia, Dose Escalation Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in Patients With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'SIM-63-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sevacizumab', 'description': '2mg/kg、5mg/kg、7.5mg/kg、10mg/kg、12.5mg/kg、or 15mg/kg. d1, d29, d43, d57', 'interventionNames': ['Drug: Sevacizumab']}], 'interventions': [{'name': 'Sevacizumab', 'type': 'DRUG', 'armGroupLabels': ['Sevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Li, MD, PhD', 'role': 'CONTACT', 'phone': '86-021-61733905'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jin Li, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Simcere Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}