Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-28 @ 7:59 PM
Study NCT ID:
NCT04805060
Status:
UNKNOWN
Last Update Posted:
2021-06-04
First Post:
2021-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2858 Injection in Subjects With Terminal Malignant 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': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Each subject started from the signing of the informed consent until 30 days after the last administration or the start of a new target indication', 'description': 'The incidence of all adverse events (AE), serious adverse events (SAE) and treatment-related adverse events (TEAEs)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Terminal Malignant Tumors']}, 'descriptionModule': {'briefSummary': 'This study is a phase I study to evaluate the safety and tolerability of TQB2858 injection in patients with advanced malignancy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with advanced malignancies diagnosed histologically and/or cytologically, where standard treatment has failed or there is no effective treatment;\n* Age: 18-75 years old;\n* ECOG score: 0 \\~ 1;\n* Expected survival of more than 3 months;\n* The main organs are functioning normally;\n* Women of childbearing age must be negative for serum or urine HCG within 7 days prior to study enrollment and must be non-lactating;Patients should agree to use contraception during the study period and for 6 months after the study period.\n* Patients voluntarily joined the study and signed the informed consent, showing good compliance.\n\nExclusion Criteria:\n\n-Complicated disease and history: A) Has developed other malignant tumors within 2 years or is currently suffering from the same tumor; B) unmitigated toxic reactions above CTC AE grade 1 due to any prior treatment, excluding hair loss and peripheral sensory nerve disorders; C) received major surgical treatment or significant traumatic injury (excluding needle biopsy) within 28 days prior to the commencement of study treatment; D) Long-term unhealed wounds or fractures; E) The occurrence of arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; F) People with a history of psychotropic substance abuse and inability to quit or with mental disorders; G) subjects with any severe and/or uncontrolled disease;"\n\n-Tumor-related symptoms and treatment: A) had undergone surgery, chemotherapy, radiation or other anticancer therapy within 4 weeks prior to the start of study treatment (washout period was calculated from the end of the last treatment); B) Chinese patent drugs with anti-tumor indications specified in the NMPA approved drug specifications (including compound cantharide capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea oil injection/capsule, Xiaoaoping tablet/injection, Huabenin capsule, etc.) were received within 2 weeks before the start of the study; C) previously received immunodouble antibody therapy targeting the same target of TQB2858 injection; D) uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (as determined by the investigator); E) Patients with brain metastases whose symptoms stabilized less than 4 weeks after discontinuation of dehydrants and steroids;"\n\n-Research Treatment Related: A) a history of live attenuated vaccine vaccination within 28 days prior to the study treatment initiation or a planned live attenuated vaccine vaccination during the study period; B) Previous history of severe allergy to macromolecular drugs or known components of TQB2858 injection; C) Study the occurrence of active autoimmune disease requiring systemic treatment (e.g., use of palliative drugs, corticosteroids, or immunosuppressants) within 2 years prior to treatment initiation.Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic; D) have been diagnosed with immunodeficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy.(dose of \\>10mg/ day prednisone or other equivalent efficacy hormone), and continued to use within 2 weeks of the first administration;" Participants had participated in other antitumor drug clinical trials in the previous 4 weeks;\n\n-Subject who, in the Investigator\'s judgment, has a concomitant disease that seriously endangers the subject\'s safety or affects the completion of the study, or is considered unsuitable for inclusion for other reasons.'}, 'identificationModule': {'nctId': 'NCT04805060', 'briefTitle': 'A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2858 Injection in Subjects With Terminal Malignant Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Phase I, Open-label, Dose Escalation Study to Evaluate the Tolerance and Pharmacokinetics of TQB2858 Injection in Subjects With Terminal Malignant Tumor', 'orgStudyIdInfo': {'id': 'TQB2858-I-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQB2858 injection', 'description': 'TQB2858 administered intravenously (IV) once every 3 week', 'interventionNames': ['Drug: TQB2858 injection']}], 'interventions': [{'name': 'TQB2858 injection', 'type': 'DRUG', 'description': 'TQB2858 administered intravenously (IV) on Day 1 of each 21-day. The established dose of TQB2858 is diluted with normal saline \\[0.9% (w/v) sodium chloride solution\\], and the infusion time is 60 ± 10 min.', 'armGroupLabels': ['TQB2858 injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Cheng, Doctor', 'role': 'CONTACT', 'email': 'jl.cheng@163.com', 'phone': '+86-0431-80596315'}], 'facility': 'Jinlin Cancer Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Ying Cheng, Doctor', 'role': 'CONTACT', 'email': 'jl.cheng@163.com', 'phone': '+86-0431-80596315'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}