A Phase 1/2 interventional study of MR001 and Irinotecan Liposome Injection combined with 5-FU/LV in Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by Shenzhen Majory Biotechnology Co., Ltd.. Recruiting at 4 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Shenzhen Majory Biotechnology Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
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.
Shenzhen Majory Biotechnology Co., Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MR001, 2mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration
Drug: MR001 · Drug: Irinotecan Liposome Injection combined with 5-FU/LV
MR001, 4mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration
Drug: MR001 · Drug: Irinotecan Liposome Injection combined with 5-FU/LV
MR001, 6mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration
Drug: MR001 · Drug: Irinotecan Liposome Injection combined with 5-FU/LV
MR001, 2mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
Drug: MR001 · Drug: Nab-paclitaxel · Drug: Gemcitabine (GEM)
MR001, 4mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
Drug: MR001 · Drug: Nab-paclitaxel · Drug: Gemcitabine (GEM)
MR001, 6mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
Drug: MR001 · Drug: Nab-paclitaxel · Drug: Gemcitabine (GEM)
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
Drug: MR001 · Drug: Irinotecan Liposome Injection combined with 5-FU/LV · Drug: Nab-paclitaxel · Drug: Gemcitabine (GEM)
Intravenous infusion
Per locally approved formulation
Per locally approved formulation
Per locally approved formulation
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Time frame: Approximately 12 months
Maximum Tolerated Dose (MTD) of MR001
The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules
Time frame: Approximately 12 months
Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0
Time frame: Approximately 30 months
Objective Response Rate (ORR)
Time frame: Approximately 24 months
Best Overall Response (BOR)
Time frame: Approximately 24 months
Disease control rate (DCR)
Time frame: Approximately 24 months
Recommended Phase II Dose (RP2D) of MR001 in combination with standard chemotherapy regimens in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
Time frame: Approximately 12 months
Progressionfree survival (PFS)
Time frame: Approximately 24 months
Overall survival (OS)
Time frame: Approximately 30 months
Area Under the Plasma ConcentrationTime Curve (AUC) of MR001
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Maximum Plasma Concentration (Cmax) of MR001
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Half-life (T1/2) of MR001
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Incidence of Antidrug Antibodies (ADA) to MR001
Time frame: Predose in every 4 cycles for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Change from baseline at different time points for Th1 in plasma
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Change from baseline at different timepoints for Th2 in plasma
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Change from baseline at different timepoints for TGF-β1 in plasma
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Change from baseline at different time points for CD4 in plasma
Time frame: Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Plan to share: No
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Shenzhen Majory Biotechnology Co., Ltd.