Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-27 @ 9:41 PM
Study NCT ID:
NCT05821595
Status:
UNKNOWN
Last Update Posted:
2023-06-27
First Post:
2023-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
JYB1907 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-24', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'until either 28 days after last dose of study drug or initiation of new anticancer therapy, whichever occurs first.', 'description': 'Adverse events, and changes from baseline in vital signs,etc.'}], 'secondaryOutcomes': [{'measure': 'Serum concentrations of JYB1907', 'timeFrame': 'until 28 days after last dose of study drug', 'description': 'JYB1907 assessed by pre-specified methods, and related pharmacokinetic parameters analysis'}, {'measure': 'Serum concentrations of Immunogenicity Analysis', 'timeFrame': 'until 28 days after last dose of study drug', 'description': 'immunogenicity of JYB1907 assessed by pre-specified methods, and related immunogenic features analysis'}, {'measure': 'Serum concentrations of Preliminary antitumor activity', 'timeFrame': 'until 28 days after last dose of study drug', 'description': 'To evaluate the preliminary antitumor activity of JYB1907 in patients with advanced solid tumors assessed by Recist1.1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'A Phase I, Multi-center, Open-label Study with Dose-escalation and Multiple Expansion Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JYB1907 in Subjects with Advanced Solid Tumors', 'detailedDescription': 'Dose escalation This part is meant to evaluate the safety, tolerability, PK, immunogenicity, preliminary antitumor activity, the MTD and RP2D of JYB1907 in patients with histologically or cytologically confirmed advanced solid tumors.\n\nExpansion cohort The antitumor activity, safety, tolerability, PK and immunogenicity of JYB1907 will be further evaluated in other cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to provide written informed consent voluntarily;\n2. Age ≥18, male or female;\n3. Have at least one evaluable lesion (Dose escalation) or measurable lesion;\n4. Expected survival ≥12 weeks；\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;\n\nExclusion Criteria:\n\n1. Received within 4 weeks before the initial treatment, or scheduled during the study to receive a major surgery, live attenuated vaccines, or any anti-tumor therapy.\n2. With severe tumor complications.\n3. Pregnant or lactating women, or positive serum pregnancy test;\n4. Concurrent participation in another interventional study；\n5. With other diseases or clinical abnormalities assessed by the Investigator as ineligible.'}, 'identificationModule': {'nctId': 'NCT05821595', 'briefTitle': 'JYB1907 in Subjects With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jemincare'}, 'officialTitle': 'A Phase I, Multi-center, Open-label Study With Dose-escalation and Multiple Expansion Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JYB1907 in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'JY190701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JYB1907 Dose 1', 'description': 'Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.\n\nThe dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration.', 'interventionNames': ['Drug: JYB1907']}, {'type': 'EXPERIMENTAL', 'label': 'JYB1907 Dose 2', 'description': 'Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.\n\nThe dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration.', 'interventionNames': ['Drug: JYB1907']}, {'type': 'EXPERIMENTAL', 'label': 'JYB1907 Dose 3', 'description': 'Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.\n\nThe dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration.', 'interventionNames': ['Drug: JYB1907']}, {'type': 'EXPERIMENTAL', 'label': 'JYB1907 Dose 4', 'description': 'Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.\n\nThe dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration.', 'interventionNames': ['Drug: JYB1907']}, {'type': 'EXPERIMENTAL', 'label': 'JYB1907 Dose 5', 'description': 'Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.\n\nThe dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration.', 'interventionNames': ['Drug: JYB1907']}], 'interventions': [{'name': 'JYB1907', 'type': 'DRUG', 'otherNames': ['TGF-β inhibitor'], 'description': 'for injection', 'armGroupLabels': ['JYB1907 Dose 1', 'JYB1907 Dose 2', 'JYB1907 Dose 3', 'JYB1907 Dose 4', 'JYB1907 Dose 5']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Guorui Wang', 'role': 'CONTACT', 'email': 'wangguorui@jemincare.com', 'phone': '+86 18115772113'}], 'overallOfficials': [{'name': 'Ning Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The study has been completed at all study sites for at least 2 years;', 'ipdSharing': 'YES', 'description': 'The results of this study will be published or presented at scientific meetings in a timely, objective, and clinically meaningful manner that is consistent with good science, industry and regulator guidance, and the need to protect the intellectual property of the sponsor, regardless of the outcome of the trial. The data generated in this clinical trial are the exclusive property of the sponsor and are confidential. For multicenter studies, the first publication or disclosure of study results shall be a complete, joint multicenter publication or disclosure coordinated by the sponsor. Thereafter, any secondary publications will reference the original publication(s). Authorship will be determined by mutual agreement and all authors must meet the criteria for authorship established by the International Committee of Medical Journal Editors.', 'accessCriteria': "* The results of the study in their entirety have been publicly disclosed by or with the consent of the sponsor in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years;\n* No such communication, presentation, or publication will include the sponsor's confidential information;\n* Each investigator agrees to submit all manuscripts or congress abstracts and posters/presentations to the sponsor at least 30 days prior to submission. This allows the sponsor to protect confidential information, provide comments based on information from other studies that may not yet be available to the investigator, and ensure scientific and clinical accuracy."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jemincare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}