Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT06404905
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of BT02 in Patients 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', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-21', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-05-04', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicity', 'timeFrame': 'Within day 28 after administration', 'description': 'safety'}, {'measure': 'Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'Within day 28 after administration', 'description': 'Safety'}, {'measure': 'Maximum tolerated dose', 'timeFrame': 'Within day 28 after administration', 'description': 'Maximum tolerated dose'}], 'secondaryOutcomes': [{'measure': 'The Pharmacokinetics characteristics of BT02', 'timeFrame': 'Within day 28 after administration', 'description': 'Levels of BT02 in blood'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.', 'description': 'The time from the date of first study treatment to the first occurrence of disease progression.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.', 'description': 'The time from the date of first study treatment to death from any cause.'}, {'measure': 'Duration of response', 'timeFrame': 'From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.', 'description': 'The time from first occurrence of a documented response to disease progression.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.', 'description': 'The sum of the proportion of subjects with CR or PR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Solid Tumors'], 'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors', 'detailedDescription': 'Overall study design:\n\nThis is an open-label, FIH, Phase I / II study of BT02 to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of BT02 in adult patients with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 at the time of signing the informed consent form, male or female;\n2. Patients must have histologically or cytologically confirmed diagnosis of advanced solid tumor;\n3. Adequate organ and hematologic function;\n4. Patients must have at least measurable or evaluable lesion in phase I and measurable lesion in phase II according to RECIST 1.1;\n5. ECOG performance status 0\\~1;\n6. Life expectancy ≥ 3 months;\n7. Good compliance and be willing to follow-up visit.\n\nExclusion Criteria:\n\n1. Receive treatment before study as below:\n\n a) Previous systematic anti-cancer therapy;\n2. Active or prior documented autoimmune disease within past 2 years;\n3. History of clinically significant cardiovascular disease;\n4. Significant acute or chronic infections;\n5. Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity;\n6. Any prior Grade≥3 irAE while receiving immunotherapy;\n7. Unstable brain metastasis or meningeal metastasis with clinical symptoms;\n8. Patients with mental disorders or poor compliance;\n9. Known alcohol or drug abuse;\n10. Other severe systemic diseases or conditions that unsuitable for participating in this study in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT06404905', 'acronym': 'BT02', 'briefTitle': 'Clinical Trial of BT02 in Patients With Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'BT02-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BT02 treatment', 'description': 'BT02 given intravenously administer in patients with advanced solid tumors.', 'interventionNames': ['Drug: BT02 monoclonal antibody injection']}], 'interventions': [{'name': 'BT02 monoclonal antibody injection', 'type': 'DRUG', 'description': 'It is expected to include 10-30 patients assigned to dose escalation cohorts.', 'armGroupLabels': ['BT02 treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000021', 'city': 'Beijing', 'state': 'Biejing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ning Li, Doctor', 'role': 'CONTACT', 'email': 'lining@cicams.ac.cn', 'phone': '800-555-5555'}, {'name': 'Li, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Institute and Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ning Li, Dr', 'role': 'CONTACT', 'email': 'lining@cicas.ac.cn', 'phone': '86 +15601395554'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}