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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

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllShenzhen Majory Biotechnology Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Histologically or cytologically confirmed locally advanced or metastatic PDAC, progressed after only one prior line of systemic therapy. * At least one measurable lesion per RECIST v1.1. * ECOG Performance Status of 0-1. * Life expectancy \>3 months. * Adequate organ and marrow function as defined by laboratory parameters. * Voluntarily sign the informed consent form. Exclusion Criteria: * Known hypersensitivity to MR001 or similar monoclonal antibodies. * Requirement for systemic immunosuppressive therapy within 14 days before first dosing. * Uncontrolled active infections or concurrent malignancies. * Not adequately controlled active brain metastases or leptomeningeal metastasis. * Clinically significant cardiovascular, renal, or hepatic disorders. * Pregnant or breastfeeding women. * Any other circumstances which the investigator considers may increase risks to subjects or interfere with the results of the trial.
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What it tests

  • MR001
  • Irinotecan Liposome Injection combined with 5-FU/LV
  • Nab-paclitaxel
  • Gemcitabine (GEM)
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Where

4 sites
Beijing Tsinghua Changgung Hospital
Beijing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
The First Hospital of Jilin University
Changchun, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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