A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy
MR001Irinotecan Liposome Injection combined with 5-FU/LVNab-paclitaxelGemcitabine (GEM)
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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants who experience one or more dose-limiting toxicities (DLTs) — Approximately 12 months
Maximum Tolerated Dose (MTD) of MR001 — Approximately 12 months The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules
Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0 — Approximately 30 months
Objective Response Rate (ORR) — Approximately 24 months
Best Overall Response (BOR) — Approximately 24 months
Disease control rate (DCR) — Approximately 24 months
Trial sites (4)
Facility
City
Region
Status
Beijing Tsinghua Changgung Hospital
Beijing
Beijing Municipality
Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
Guangdong
Active Not Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Not Yet Recruiting
The First Hospital of Jilin University
Changchun
Jilin
Not Yet Recruiting
More Shenzhen Majory Biotechnology Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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