Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-04 @ 4:55 PM
Study NCT ID:
NCT03460457
Status:
UNKNOWN
Last Update Posted:
2018-03-09
First Post:
2018-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance and Pharmacokinetics of TQB2450
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-02', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum tolerated dose(MTD)', 'timeFrame': '21 days'}, {'measure': 'dose-limiting toxicity(DLT)', 'timeFrame': '21 days'}], 'secondaryOutcomes': [{'measure': 'Peak Plasma Concentration(Cmax)', 'timeFrame': '21 days'}, {'measure': 'Peak time（Tmax）', 'timeFrame': '21 days'}, {'measure': 'Half life（t1/2）', 'timeFrame': '21 days'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': '21 days'}, {'measure': 'Clearance（CL）', 'timeFrame': '21 days'}, {'measure': 'objective response rate(ORR)', 'timeFrame': 'evaluated in the end of each 3 cycles up to intolerance the toxicity or progression disease (up to 24 months)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tumor']}, 'referencesModule': {'references': [{'pmid': '38188467', 'type': 'DERIVED', 'citation': 'Xue J, Xue L, Tang W, Ge X, Zhao W, Li Q, Peng W, Dai C, Guo Y, Li J. TQB2450 in patients with advanced malignant tumors: results from a phase I dose-escalation and expansion study. Ther Adv Med Oncol. 2024 Jan 6;16:17588359231220516. doi: 10.1177/17588359231220516. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'To study the pharmacokinetic characteristics of TQB2450 in the human body, recommend a reasonable regimen for subsequent research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with advanced malignancy diagnosed with pathology or cytology who have failed standard treatment or no standard treatment;\n* 18-70 years old;Eastern Cooperative Oncology Group performance status:0-1,Life expectancy of more than 3 months;\n* Main organs function is normal;\n* Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped;\n* Patients should be voluntary and sign the informed consents before taking part in the study;\n\nExclusion Criteria:\n\n* Patients who have received programmed cell death protein 1(PD-1) or programmed cell death protein ligand(PD-L1) antibody treatment;\n* Patients who had any\\> 3 degree immune-related adverse event during any previous immunotherapy received;\n* Appeared severe hypersensitivity after taking other monoclonal antibody drugs;\n* Other malignancies have been diagnosed in the past 2 years except cured or locally curable cancers, such as cutaneous or squamous cell carcinoma, superficial bladder cancer, cervical cancer or orthotopic carcinoma of the breast;\n* Known spinal cord compression, cancer meningitis patients, new onset of central nervous system metastasis or stable control of symptoms in patients with brain metastases less than 4 weeks; asymptomatic and stable imaging without the need for corticosteroid treatment；\n* Patients with hypothyroidism over 2 degrees;\n* Patients with active, or who have had, and are likely to relapse, autoimmune diseases; the following patients are enrolled: skin disorders without systemic treatment (eg vitiligo, psoriasis, hair loss);\n* Patients treated with glucocorticoids or other immunosuppressive agents within 4 weeks prior to dosing;\n* Interstitial lung disease or non-contagious pneumonia (including past history and current illness); uncontrolled systemic diseases including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc. except for radiotherapy-induced interstitial pneumonitis;\n* Serious chronic or active infections require systemic antibacterial, antifungal or antiviral treatment (allowing antiviral treatment in patients with hepatocellular carcinoma), including tuberculosis infection;\n* Unstable pleural effusion, pericardial effusion or ascites;\n* Significant cardiovascular diseases such as heart failure of New York Heart Academy(NYHA) Class 2 and above, myocardial infarction within the past 3 months, unstable arrhythmias (including QT interval ≥480 ms) or unstable Angina;\n* Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;\n* Hypertension (systolic BP ≥140 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication;\n* Hepatitis B virus patients with active replication (DNA\\> 500 cps / mL), hepatitis C;\n* The first medication interval from the patient: the last chemotherapy for at least 4 weeks, biological products at least five half-lives;\n* The first medication interval from the patient: the last chemotherapy for at least 4 weeks, biological products at least five half-lives;\n* Inoculated with vaccine or attenuated vaccine within 4 weeks before first administration;\n* Major surgery, or unhealed wounds, ulcers or fractures within 4 weeks prior to the first dose;'}, 'identificationModule': {'nctId': 'NCT03460457', 'briefTitle': 'Tolerance and Pharmacokinetics of TQB2450', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'Phase I Study of Tolerance and Pharmacokinetics of TQB2450 Injection', 'orgStudyIdInfo': {'id': 'TQB2450-I-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQB2450', 'interventionNames': ['Drug: TQB2450']}], 'interventions': [{'name': 'TQB2450', 'type': 'DRUG', 'description': 'Pharmacokinetics/Dynamics Study', 'armGroupLabels': ['TQB2450']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}