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A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy
Sponsor: Shenzhen Majory Biotechnology Co., Ltd.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2025-12-24
Completion Date
2028-12-22
Last Updated
2025-12-31
Healthy Volunteers
No
Conditions
Interventions
MR001
Intravenous infusion
Irinotecan Liposome Injection combined with 5-FU/LV
Per locally approved formulation
Nab-paclitaxel
Per locally approved formulation
Gemcitabine (GEM)
Per locally approved formulation
Locations (1)
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China