Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-02-25 @ 5:39 PM
Study NCT ID:
NCT07235202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-06-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who experience one or more dose-limiting toxicities (DLTs)', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Maximum Tolerated Dose (MTD) of MR001', 'timeFrame': 'Approximately 12 months', 'description': 'The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules'}, {'measure': 'Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0', 'timeFrame': 'Approximately 30 months'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Approximately 24 months'}, {'measure': 'Best Overall Response (BOR)', 'timeFrame': 'Approximately 24 months'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Approximately 24 months'}], 'secondaryOutcomes': [{'measure': 'Recommended Phase II Dose (RP2D) of MR001 in combination with standard chemotherapy regimens in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Progressionfree survival (PFS)', 'timeFrame': 'Approximately 24 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Approximately 30 months'}, {'measure': 'Area Under the Plasma ConcentrationTime Curve (AUC) of MR001', 'timeFrame': 'Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MR001', 'timeFrame': 'Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)'}, {'measure': 'Half-life (T1/2) of MR001', 'timeFrame': 'Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)'}, {'measure': 'Incidence of Antidrug Antibodies (ADA) to MR001', 'timeFrame': 'Predose in every 4 cycles for approximately 18 months (each cycle = 2 weeks or 4 weeks)'}, {'measure': 'Change from baseline at different time points for Th1 in plasma', 'timeFrame': 'Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)'}, {'measure': 'Change from baseline at different timepoints for Th2 in plasma', 'timeFrame': 'Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)'}, {'measure': 'Change from baseline at different timepoints for TGF-β1 in plasma', 'timeFrame': 'Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)'}, {'measure': 'Change from baseline at different time points for CD4 in plasma', 'timeFrame': 'Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MR001', 'PDAC', 'CD4', 'TGF-β1'], 'conditions': ['Pancreatic Ductal Adenocarcinoma (PDAC)']}, 'descriptionModule': {'briefSummary': 'This Phase Ib/IIa study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 Combined with Chemotherapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after first-line therapy.', 'detailedDescription': 'This is an open-label, dose-escalation and dose-expansion Phase Ib/IIa study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 in combination with standard chemotherapy regimens in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after first-line therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced or metastatic PDAC, progressed after only one prior line of systemic therapy.\n* At least one measurable lesion per RECIST v1.1.\n* ECOG Performance Status of 0-1.\n* Life expectancy \\>3 months.\n* Adequate organ and marrow function as defined by laboratory parameters.\n* Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Known hypersensitivity to MR001 or similar monoclonal antibodies.\n* Requirement for systemic immunosuppressive therapy within 14 days before first dosing.\n* Uncontrolled active infections or concurrent malignancies.\n* Not adequately controlled active brain metastases or leptomeningeal metastasis.\n* Clinically significant cardiovascular, renal, or hepatic disorders.\n* Pregnant or breastfeeding women.\n* Any other circumstances which the investigator considers may increase risks to subjects or interfere with the results of the trial.'}, 'identificationModule': {'nctId': 'NCT07235202', 'briefTitle': 'A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen Majory Biotechnology Co., Ltd.'}, 'officialTitle': 'An Open-label, Dose-escalation and Dose-expansion Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MR001 in Combination With Standard Chemotherapy Regimens in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Who Have Progressed After First-line Therapy', 'orgStudyIdInfo': {'id': 'MJR-MR001-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU', 'description': 'MR001, 2mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration', 'interventionNames': ['Drug: MR001', 'Drug: Irinotecan Liposome Injection combined with 5-FU/LV']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU', 'description': 'MR001, 4mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration', 'interventionNames': ['Drug: MR001', 'Drug: Irinotecan Liposome Injection combined with 5-FU/LV']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU', 'description': 'MR001, 6mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration', 'interventionNames': ['Drug: MR001', 'Drug: Irinotecan Liposome Injection combined with 5-FU/LV']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine', 'description': 'MR001, 2mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration', 'interventionNames': ['Drug: MR001', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine (GEM)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine', 'description': 'MR001, 4mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration', 'interventionNames': ['Drug: MR001', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine (GEM)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine', 'description': 'MR001, 6mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration', 'interventionNames': ['Drug: MR001', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine (GEM)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion Part', 'description': 'Based on the Dose escalation part results, the Investigator and Sponsor will determine one dose and dosing interval to proceed to the dose expansion study', 'interventionNames': ['Drug: MR001', 'Drug: Irinotecan Liposome Injection combined with 5-FU/LV', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine (GEM)']}], 'interventions': [{'name': 'MR001', 'type': 'DRUG', 'description': 'Intravenous infusion', 'armGroupLabels': ['Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU', 'Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU', 'Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU', 'Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine', 'Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine', 'Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine', 'Dose Expansion Part']}, {'name': 'Irinotecan Liposome Injection combined with 5-FU/LV', 'type': 'DRUG', 'description': 'Per locally approved formulation', 'armGroupLabels': ['Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU', 'Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU', 'Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU', 'Dose Expansion Part']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'description': 'Per locally approved formulation', 'armGroupLabels': ['Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine', 'Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine', 'Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine', 'Dose Expansion Part']}, {'name': 'Gemcitabine (GEM)', 'type': 'DRUG', 'description': 'Per locally approved formulation', 'armGroupLabels': ['Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine', 'Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine', 'Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine', 'Dose Expansion Part']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102218', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Jiahong Dong, MD, PhD', 'role': 'CONTACT', 'email': 'dongjiahong@mail.tsinghua.edu.cn', 'phone': '+86-10-56118899'}], 'facility': 'Beijing Tsinghua Changgung Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qingshan Xue', 'role': 'CONTACT', 'email': 'xueqs@majory.com.cn', 'phone': '+86 13332895357'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Majory Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}