Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT06649656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-21
First Post:
2024-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced 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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2024-10-17', 'studyFirstSubmitQcDate': '2024-10-17', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (AE) rate', 'timeFrame': 'From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first.', 'description': "The evaluation criteria for the nature and severity of adverse events are based on the National Cancer Institute's CommonTerminology Criteria for Adverse Events (NCI CTCAE version 5.0)."}], 'secondaryOutcomes': [{'measure': 'Time to reach maximum observed plasma concentration (Tmax)', 'timeFrame': 'Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)', 'description': 'Time to reach maximum (peak) plasma concentration following drug administration'}, {'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': 'Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)', 'description': 'The Cmax is the maximum observed plasma concentration of TQB2252.'}, {'measure': 'Elimination half-life (t1/2)', 'timeFrame': 'Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)', 'description': 'Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'up to 2 years', 'description': 'Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'up to 2 years', 'description': 'Defined as the time from the first dose of TQB2252 to the first occurrence of disease progression or death from any cause.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'up to 2 years', 'description': 'Defined as the proportion of subjects with CR, PR, or Stable Disease (SD).'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'up to 2 years', 'description': 'Defined as the time from first documented response to documented disease progression.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Cancers']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, single arm, and open design Phase I clinical trial aimed at evaluating the safety, Pharmacokinetics (PK) characteristics, immunogenicity, and preliminary efficacy of TQB2252 injection in subjects with advanced malignant tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance;\n* 18 years old ≤ 75 years old (calculated from the date of signing the informed consent form);\n* Electrocorticogram (ECOG) score ranges from 0 to 1 points;\n* Expected survival is greater than 12 weeks；\n* Confirmed to have at least one measurable lesion according to RECIST 1.1 (solid tumor) or Lugano 2014 (lymphoma) criteria；\n* Late stage malignant tumor subjects who have failed standard treatment or lack effective treatment；\n* Women of childbearing age should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study; Men should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* Has experienced or currently has other malignant tumors within the past 5 years prior to the first use of medication;\n* There are multiple factors that affect diseases related to intravenous injection and venous blood collection;\n* The adverse reactions of previous anti-tumor treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score of ≤ 1;\n* Individuals who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication;\n* Subjects who experience any bleeding or bleeding events ≥ CTCAE grade 3 within 4 weeks prior to the first administration;\n* An arterial/venous thrombotic event occurred within 6 months prior to the first administration;\n* Active viral hepatitis with poor control;\n* Active syphilis infected individuals in need of treatment;\n* History of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia;\n* Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;\n* Diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy due to a history of hepatic encephalopathy;\n* Previously experienced grade 3 or higher adverse reactions related to immunotherapy;\n* Suffering from significant cardiovascular disease;\n* Active or uncontrolled severe infections;\n* Patients with renal failure requiring hemodialysis or peritoneal dialysis;\n* History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases;\n* Individuals with epilepsy who require treatment;\n* Previously received treatment with similar anti-lag3 drugs.'}, 'identificationModule': {'nctId': 'NCT06649656', 'briefTitle': 'A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced Malignant Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced Malignant Tumors', 'orgStudyIdInfo': {'id': 'TQB2252-I-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQB2252 injection', 'description': 'This product is administered via intravenous infusion, with recommended doses of 600mg TQB2223 monoclonal antibody and 200mg penpulimab injection, administered once every 3 weeks.', 'interventionNames': ['Drug: TQB2252 injection']}], 'interventions': [{'name': 'TQB2252 injection', 'type': 'DRUG', 'description': 'TQB2252 injection is a compound preparation of TQB2223 monoclonal antibody (LAG-3) and penpulimab (PD-1), with a specification of 300mg TQB2223 monoclonal antibody and 100mg (20ml) penpulimab per bottle.', 'armGroupLabels': ['TQB2252 injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '519041', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Xing Zhang, Doctor', 'role': 'CONTACT', 'email': 'zhangxing@sysucc.org.cn', 'phone': '13610223691'}], 'facility': "Guangdong provincial people's hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xing Zhang, Doctor', 'role': 'CONTACT', 'email': 'zhangxing@sysucc.org.cn', 'phone': '13610223691'}, {'name': 'Qingqing Cai, Doctor', 'role': 'CONTACT', 'email': 'caiqq@sysucc.org.cn', 'phone': '13798101121'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}