Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-01 @ 10:18 PM
Study NCT ID:
NCT06662669
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-29
First Post:
2024-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-27', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-10-27', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': 'From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.', 'description': 'The proportion of subjects who have a complete response or partial response.'}, {'measure': 'Progression-free survival', 'timeFrame': 'From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.', 'description': 'Progression-free survival is defined clinically as the time from randomization to disease progression or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Disease control rate', 'timeFrame': 'From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.', 'description': 'The proportion of subjects who have a complete response, partial response and stable disease.'}, {'measure': 'Adverse events', 'timeFrame': 'From time of first dose to 30 days after the last dose.', 'description': 'Incidence of adverse events evaluated by NCI CTCAE v5.0'}, {'measure': 'Plasma concentration of YL-13027 and HY-0102', 'timeFrame': 'From one hour before the first dose to the last dose up to 24months.', 'description': 'This composite endpoint will measure the plasma concentration of YL-13027 and HY-0102.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'In Phase 1b study, six subjects will be enrolled in Arm A (YL-13027 + AG regimen) and Arm B (HY-0102 + AG regimen). The first 12 subjects will be evaluated for safety after one cycle. After safety assessment, subjects will start to enroll in Arm C (YL-13027 + HY-0102 + AG regimen). Each group is planned to include 12-20 subjects. According to the safety and efficacy results of 3 arms of subjects in phase Ib, 1-2 groups were selected for expansion, and a randomized controlled study will be conducted with the standard treatment AG （Arm 4）regimen chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject aged between 18 and 75 years.\n* Subject has histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.\n* Subject has at least one evaluable metastatic lesion according to RECIST 1.1 criteria;\n* Subject has an ECOG score of 0-1 and is expected to survive more than 3 months;\n* Subjects have a good level of organ function.\n\nExclusion Criteria:\n\n* Subject suitable for potentially curative surgery.\n* The subject confirmed by tissue or cytology as other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, etc.\n* The subject has previously received gemcitabine and nab-paclitaxel combination therapy within 6 months of progression or intolerance.'}, 'identificationModule': {'nctId': 'NCT06662669', 'briefTitle': 'YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai YingLi Pharmaceutical Co. Ltd.'}, 'officialTitle': 'A Randomized, Open, Parallel-controlled, Multi-center , Phase Ib/Ⅱ Clinical Trial of YL-13027 and/or HY-0102 Combined With AG（Nab-paclitaxel and Gemcitabine) Regimen Chemotherapy for Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'YL-13027-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GroupA (YL-13027+AG )', 'description': 'YL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W', 'interventionNames': ['Drug: YL-13027', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (HY-0102+AG )', 'description': 'HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W', 'interventionNames': ['Drug: HY-0102', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Group C (YL-13027+HY-0102+AG)', 'description': 'YL-13027: 180mg BID PO HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W', 'interventionNames': ['Drug: YL-13027', 'Drug: HY-0102', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D (AG)', 'description': 'Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}], 'interventions': [{'name': 'YL-13027', 'type': 'DRUG', 'otherNames': ['YL-13027 tablet'], 'description': 'YL-13027 is a small molecule inhibitor of the TGF-βRI target.', 'armGroupLabels': ['Group C (YL-13027+HY-0102+AG)', 'GroupA (YL-13027+AG )']}, {'name': 'HY-0102', 'type': 'DRUG', 'otherNames': ['HY-0102 injection'], 'description': 'HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.', 'armGroupLabels': ['Group B (HY-0102+AG )', 'Group C (YL-13027+HY-0102+AG)']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemcitabine Hydrochloride for Injection'], 'description': 'Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.', 'armGroupLabels': ['Group B (HY-0102+AG )', 'Group C (YL-13027+HY-0102+AG)', 'Group D (AG)', 'GroupA (YL-13027+AG )']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'otherNames': ['Paclitaxel for Injection (albumin bound)'], 'description': 'Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis', 'armGroupLabels': ['Group B (HY-0102+AG )', 'Group C (YL-13027+HY-0102+AG)', 'Group D (AG)', 'GroupA (YL-13027+AG )']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhingqiang Wang', 'role': 'CONTACT', 'email': 'wangzhq@sysucc.org.cn', 'phone': '020-87343571'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai YingLi Pharmaceutical Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}