Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05198505
Status:
UNKNOWN
Last Update Posted:
2022-05-02
First Post:
2022-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial of TQB2868 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': 280}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-29', 'studyFirstSubmitDate': '2022-01-19', 'studyFirstSubmitQcDate': '2022-01-19', 'lastUpdatePostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'up to 10 months', 'description': 'DLT definition: the subject has the following adverse events related to the test drug within one treatment cycle (21 days) after the first administration.\n\n1. Grade ≥ 3 neutropenia with fever; Grade 4 neutropenia that cannot be recovered within 3 days after symptomatic treatment; Grade 3 anemia that cannot be recovered within 14 days;\n\n ≥ Grade 3 thrombocytopenia with bleeding; Other hematological toxicity above grade 4 (inclusive);\n2. ≥ Grade 3 non hematological toxicity; Nausea, vomiting, diarrhea, rash and electrolyte disorder that cannot be recovered to grade ≤ 2 within 7 days after symptomatic treatment; Grade 3 general fatigue, fatigue and headache with duration ≥ 7 days; Laboratory examination abnormalities with isolated ≥ grade 3 and significant clinical symptoms;\n3. Adverse events related to ≥ grade 3 infusion reaction occurred, and did not return to normal within 6 hours after stopping infusion'}, {'measure': 'Recommended Phase II Dose (RP2D)', 'timeFrame': 'up to 10 months', 'description': 'To evaluate RP2D of TQB2868 injection in adult patients with advanced malignant tumors'}, {'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'up to 10 months', 'description': 'Defined as the highest dose when dose-limiting toxicity (DLT) occurred in less than 33% of subjects.'}, {'measure': 'All adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)', 'timeFrame': 'up to 17 months', 'description': 'ncidence of all adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)'}], 'secondaryOutcomes': [{'measure': 'Time to reach maximum(peak )plasma concentration following drug administration (Tmax)', 'timeFrame': 'up to 17 months', 'description': 'To characterize the pharmacokinetics of TQB2868 by assessment of time to reach maximum plasma concentration after single and multiple dosing'}, {'measure': 'Maximum (peak) plasma drug concentration (Cmax)', 'timeFrame': 'up to 17months', 'description': 'Cmax is the maximum plasma concentration of TQB2868.'}, {'measure': 'Maximum (peak) steady-state plasma drug concentration during a dosage interval (Css-max)', 'timeFrame': 'up to 17 months', 'description': 'Cmax is the steady state maximum concentration of TQB2868 .'}, {'measure': 'Title：The plasma concentration time curve at steady state, from 0 to τ area under curve of time. (AUC0-τ)', 'timeFrame': 'up to 17 months', 'description': 'To characterize the pharmacokinetics of TQB2868 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time t (AUC0-t)', 'timeFrame': 'up to 17 months', 'description': 'To characterize the pharmacokinetics of TQB2868 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.'}, {'measure': 'Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)', 'timeFrame': 'up to 17 months', 'description': 'To characterize the pharmacokinetics of TQB2868 by assessment of area under the plasma concentration time curve from the first dose to infinity.'}, {'measure': 'Apparent total clearance of the drug from plasma after oral administration (CL/F)', 'timeFrame': 'up to 17 months', 'description': 'CL/F is total clearance rate for TQB2868.'}, {'measure': 'Elimination half-life (t1/2)', 'timeFrame': 'up to 17 months', 'description': 't1/2 is time it takes for the blood concentration of TQB2868 to drop by half.'}, {'measure': 'Apparent volume of distribution of intravenous infusion(Vss/F)', 'timeFrame': 'up to 17 months', 'description': 'Steady-state apparent volume of distribution of TQB2868 injection by intravenous infusion'}, {'measure': 'Elimination rate constant(λ)', 'timeFrame': 'up to 17 months', 'description': 'λ is the elimination rate constant when TQB2868 participates in the calculation of metabolism in the body'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time 24h.( AUC0-24h)', 'timeFrame': 'up to 17 months', 'description': 'Characterize the pharmacokinetics of TQB2868 by evaluating the area under the plasma concentration-time curve from the first administration to 24h'}, {'measure': 'Mean residence time (MRT)', 'timeFrame': 'up to 17 months', 'description': 'MRT describes the average time that TQB2868 remains in the body.'}, {'measure': 'Minimum steady-state plasma drug concentration during a dosage interval (Css-min)', 'timeFrame': 'up to 17 months', 'description': 'Css-min is the minimum plasma concentration of TQB2868.'}, {'measure': 'Degree of fluctuation(DF)', 'timeFrame': 'up to 17 months', 'description': 'DF is the volatility coefficient of TQB2868.'}, {'measure': 'Average steady-state plasma drug concentration during multiple-dose administration (Css-avg)', 'timeFrame': 'up to 17 months', 'description': 'Css-avg is the average of steady-state plasma concentration of TQB2868 .'}, {'measure': 'Anti-drug antibodies(ADA)', 'timeFrame': 'up to 17 months', 'description': 'ADA is antibodies that make TQB2868 clear in the body quickly'}, {'measure': 'Receptor Occupancy(RO)', 'timeFrame': 'up to 17 months', 'description': 'RO is a receptor occupancy for TQB2868 involved in metabolism in the body'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'up to 29 months', 'description': 'PFS is defined as the time from the first treatment to the first disease progression or death from any cause'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'up to 29 months', 'description': 'Percentage of participants achieving complete response (CR) and partial response (PR).'}, {'measure': 'Disease control rate（DCR）', 'timeFrame': 'up to 29 months', 'description': 'Percentage of participants achieving CR and PR and stable disease (SD).'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'up to 29 months', 'description': 'The period from the participants first achieving CR or PR to disease progression.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to 29 months', 'description': 'OS is defined as the time from the first administration to all-cause death.'}, {'measure': 'PD-L1 expression in tumor tissue', 'timeFrame': 'up to 17 months', 'description': 'To evaluate the expression of PD -L1'}, {'measure': 'TGF-β expression in blood samples', 'timeFrame': 'up to 17 months', 'description': 'To evaluate the expression of TGF-β'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignant Tumor']}, 'descriptionModule': {'briefSummary': 'The TQB2868 protein in this study targeted programmed cell death protein 1 (PD-1) and transforming growth factor-β (TGF-β). The bifunctional fusion protein targets and neutralizes TGF-β in the tumor microenvironment. On the basis of inhibiting PD-1 / programmed death ligand 1 (PD-L1) pathway, T cells can restore activity, enhance immune response, and more effectively improve the effect of inhibiting tumor occurrence and development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1 Subjects voluntarily join the study and sign an informed consent form.\n* 2 Age: 18-75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group Performance status (ECOG PS) score: 0\\~1 points.\n* 3 Advanced malignant tumors clearly diagnosed by histology or cytology.\n* 4 Patients with advanced malignant tumors who have been diagnosed by tissue and/or cytology and have failed standard treatments or lack effective treatment options.\n* 5 The main organs are in good function, and the following examination results are good: routine blood examination, biochemical examination, blood coagulation function examination, heart color Doppler ultrasound evaluation.\n* 6 Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study; serum pregnancy/urine within 7 days before study entry The pregnancy test is negative and must be a non-lactating subject; male subjects should agree that contraception must be used during the study period and within 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* 1 Combined diseases and medical history:\n\n 1. Has had other malignant tumors within 3 years before the first medication. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieve disease-free survival (DFS) for 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \\[ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\\];\n 2. Unrelieved toxic reactions higher than Common Terminology Criteria Adverse Events (CTC AE) level 1 or higher caused by any previous treatment, excluding hair loss;\n 3. Major surgical treatment, obvious traumatic injury or long-term unhealed wounds or fractures have been received within 28 days before the first medication;\n 4. Arterial/venous thrombosis occurred within 6 months before the first administration, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;\n 5. Existence of active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms;\n 6. People who have a history of psychotropic drug abuse and cannot be quit or have mental disorders;\n 7. Previous recipients of allogeneic bone marrow transplantation or solid organ transplantation.\n 8. Subjects with any severe and / or uncontrolled disease.\n* 2 Tumor-related symptoms and treatment:\n\n 1. Have received chemotherapy, radiotherapy or other anti-cancer therapies within 4 weeks before the first medication (the washout period will be calculated from the end of the last treatment); if you have received local radiotherapy in the past, you can join the group if the following conditions are met: End of radiotherapy more than 4 weeks from the start of the study treatment (brain radiotherapy is more than 2 weeks); and the target lesion selected for this study is not in the radiotherapy area; or the target lesion is located in the radiotherapy area, but progress has been confirmed.\n 2. Received Chinese patent medicine treatment with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the first medication;\n 3. Have previously received immunological double-antibody therapeutic drugs against the same target of TQB2868 injection;\n 4. Uncontrollable pleural effusion, pericardial effusion or ascites that still needs to be drained repeatedly (investigator's judgment);\n 5. Known to have spinal cord compression, cancerous meningitis, accompanied by brain metastasis symptoms, or symptom control time less than 2 weeks;\n* 3 Research and treatment related:\n\n 1. The history of live attenuated vaccine vaccination within 28 days before the first administration or the planned live attenuated vaccine vaccination during the research period;\n 2. Those who have had severe hypersensitivity reactions after using macromolecular drugs;\n 3. An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, corticosteroids, or immunosuppressive agents) occurred within 2 years before the first medication. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;\n 4. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose\\>10mg/day prednisone or other curative hormones), and continue within 2 weeks of the first administration in use;\n* 4 Participated in other anti-tumor drug clinical trials within 4 weeks before the first medication;\n* 5 According to the judgment of the researcher, there are situations that seriously endanger the safety of the subjects or affect the completion of the research by the subjects."}, 'identificationModule': {'nctId': 'NCT05198505', 'briefTitle': 'Clinical Trial of TQB2868 Injection in Subjects With Advanced Malignant Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'Phase I Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQB2868 Injection in Subjects With Advanced Malignant Tumors', 'orgStudyIdInfo': {'id': 'TQB2868-I-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQB2868 Injection', 'description': 'The drug was administered once every 3 weeks (administration time window: ± 3 days), the dose of each administration was 1.5-600 mg, and 3 weeks was a treatment cycle until the disease progressed or the investigator judged that it was not suitable to continue the drug use.', 'interventionNames': ['Drug: TQB2868 Injection']}], 'interventions': [{'name': 'TQB2868 Injection', 'type': 'DRUG', 'description': 'TQB2868 protein is a bi-functional fusion protein targeting PD-1 and TGF-β', 'armGroupLabels': ['TQB2868 Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Suxia Luo, Doctor', 'role': 'CONTACT', 'email': 'luosxrm@163.com', 'phone': '0371-65588009'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '276002', 'city': 'Linyi', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianhua Shi, Master', 'role': 'CONTACT', 'email': 'shijianhualy@126.com', 'phone': '0539-8127192'}], 'facility': 'Linyi Cancer Hospital', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Caicun Zhou, Doctor', 'role': 'CONTACT', 'email': 'caicunzhoudr@163.com', 'phone': '18796218833'}], 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Caicun Zhou, Doctor', 'role': 'CONTACT', 'email': 'caicunzhoudr@163.com', 'phone': '18796218833'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}