Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
Study NCT ID:
NCT04623892
Status:
UNKNOWN
Last Update Posted:
2020-11-10
First Post:
2020-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced 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': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-08', 'studyFirstSubmitDate': '2020-11-08', 'studyFirstSubmitQcDate': '2020-11-08', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'Baseline up to 28 days', 'description': 'MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': 'Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.', 'description': 'To characterize the pharmacokinetics of TQB2618 by assessment of time to reach maximum plasma concentration.'}, {'measure': 'Cmax', 'timeFrame': 'Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.', 'description': 'Cmax is the maximum plasma concentration of TQB2618 or metabolite(s).'}, {'measure': 't1/2', 'timeFrame': 'Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.', 'description': 't1/2 is time it takes for the blood concentration of TQB2618 injection or metabolite(s) to drop by half.'}, {'measure': 'AUC0-t', 'timeFrame': 'Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.', 'description': 'To characterize the pharmacokinetics of TQB2618 by assessment of area under the plasma concentration time curve from zero to infinity.'}, {'measure': 'Receptor occupation (RO)', 'timeFrame': 'Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.', 'description': 'Receptor occupation of TIM-3 after single and multiple doses'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'Up to 48 weeks', 'description': 'Percentage of participants achieving complete response (CR) and partial response (PR).'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 48 weeks', 'description': 'PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.'}, {'measure': 'Disease control rate（DCR）', 'timeFrame': 'Up to 48 weeks', 'description': 'Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 48 weeks', 'description': 'DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'TQB2618 is a TIM-3 receptor monoclonal antibody that binds to the extracellular domain of TIM-3 outside the cell to block the binding of TIM-3 to its ligand, thereby inhibiting the downstream signal transduction of TIM-3 and deactivating TIM-3 Inhibition of immune cells. The purpose of this study was to evaluate the safety, tolerability, pharmacokinetic parameters and antitumor effects of TQB2618 injection in subjects with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Diagnosed as advanced malignant solid tumors and have failed standard treatments or lack effective treatments; 2. 18-75 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks; 3. Has at least one measurable lesion; 4. The function of main organs is normal; 5. Female patients of childbearing age must be negative in serum or urine HCG within 7 days before enrollment in the study, and must be non-lactating; patients should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 6. Understood and signed an informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Has Autoimmune disease; 2. Has received allogeneic bone marrow transplantation or solid organ transplantation; 3. Has brain disease or brain metastases; 4. Has cavity effusion; 5. Has cardiovascular diseases; 6. Has immunodeficiency diseases; 7. Has liver disease; 8. Has infection; 9. Has diabetes; 10. Has a history of psychotropic drug abuse or have a mental disorder; 11. Have a history of severe allergy to macromolecular drugs or allergy to known components of TQB2618 injection; 12. Has other malignant tumors within 2 years before the first medication; 13. Has received other anti-cancer drugs or anti-cancer treatments, or major surgical operations within 4 weeks before the first medication; 14. Has received any live vaccines or vaccines to prevent infectious diseases within 4 weeks before the first medication; 15. Has received local radiotherapy within 1 week before the first medication; 16. Toxicity (excluding hair loss) caused by previous anti-tumor therapy that has not recovered to CTC AE V5.0 level 1 or below; 17. Has major wound, severe ulcer or fracture that has not healed before 1 day before the first medication; 18. Has used systemic hormones, immune agonists, inhibitors, and regulators before 1 day before the first medication; 19. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.'}, 'identificationModule': {'nctId': 'NCT04623892', 'briefTitle': 'A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'TQB2618-I-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQB2618', 'description': 'TQB2618 administered intravenously (IV) on Day 1 of each 21-day.', 'interventionNames': ['Drug: TQB2618 injection']}], 'interventions': [{'name': 'TQB2618 injection', 'type': 'DRUG', 'description': 'TQB2618 administered intravenously (IV) on Day 1 of each 21-day. The established dose of TQB2618 is diluted to 100 m with normal saline \\[0.9% (w/v) sodium chloride solution\\], and the infusion time is 60 ± 10 min.', 'armGroupLabels': ['TQB2618']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Cancer Hospital of The University of Chinese Academy of Sciences', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yun Fan, Doctor', 'role': 'CONTACT', 'email': 'fanyun@zjcc.org.cn', 'phone': '0571-88122510'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}