A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy

November 5, 2026 updated by: Shenzhen Majory Biotechnology Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 102218
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Not yet recruiting
        • Chongqing University Cancer Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
      • Shenzhen, Guangdong, China, 518020
        • Not yet recruiting
        • Shenzhen People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518172
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130015
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Zuoxing Niu
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
        • Contact:
      • Yibin, Sichuan, China, 644000
        • Not yet recruiting
        • The Second People's Hospital of Yibin
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU

MR001, 2mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration
Drug: MR001

Intravenous infusion

Drug: Irinotecan Liposome Injection combined with 5-FU/LV

Per locally approved formulation
Experimental: Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU

MR001, 4mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration
Drug: MR001

Intravenous infusion

Drug: Irinotecan Liposome Injection combined with 5-FU/LV

Per locally approved formulation
Experimental: Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU

MR001, 6mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration
Drug: MR001

Intravenous infusion

Drug: Irinotecan Liposome Injection combined with 5-FU/LV

Per locally approved formulation
Experimental: Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine

MR001, 2mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
Drug: MR001

Intravenous infusion

Drug: Nab-paclitaxel

Per locally approved formulation

Drug: Gemcitabine (GEM)

Per locally approved formulation
Experimental: Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine

MR001, 4mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
Drug: MR001

Intravenous infusion

Drug: Nab-paclitaxel

Per locally approved formulation

Drug: Gemcitabine (GEM)

Per locally approved formulation
Experimental: Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine

MR001, 6mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
Drug: MR001

Intravenous infusion

Drug: Nab-paclitaxel

Per locally approved formulation

Drug: Gemcitabine (GEM)

Per locally approved formulation
Experimental: Dose Expansion Part

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

Intravenous infusion

Drug: Irinotecan Liposome Injection combined with 5-FU/LV

Per locally approved formulation

Drug: Nab-paclitaxel

Per locally approved formulation

Drug: Gemcitabine (GEM)

Per locally approved formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: Approximately 24 months
Approximately 24 months
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Time Frame: Approximately 12 months
Approximately 12 months
Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0
Time Frame: Approximately 30 months
Approximately 30 months
Objective Response Rate (ORR)
Time Frame: Approximately 24 months
Approximately 24 months
Best Overall Response (BOR)
Time Frame: Approximately 24 months
Approximately 24 months
Maximum Tolerated Dose (MTD) of MR001
Time Frame: Approximately 12 months

The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules
Approximately 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Approximately 30 months
Approximately 30 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
Approximately 12 months
Progressionfree survival (PFS)
Time Frame: Approximately 24 months
Approximately 24 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)
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)
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)
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)
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)
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)
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)
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)
Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Majory Biotechnology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2025

Primary Completion (Estimated)

June 22, 2028

Study Completion (Estimated)

December 22, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MJR-MR001-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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