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NCT Number: NCT07235202

A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) 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.

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Tsinghua Changgung Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MR001

Drug

Intravenous infusion

Irinotecan Liposome Injection combined with 5-FU/LV

Drug

Per locally approved formulation

Nab-paclitaxel

Drug

Per locally approved formulation

Gemcitabine (GEM)

Drug

Per locally approved formulation

Primary outcomes

  1. Number of participants who experience one or more dose-limiting toxicities (DLTs)

    Time frame: Approximately 12 months

  2. Maximum Tolerated Dose (MTD) of MR001

    Time frame: Approximately 12 months

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

  3. Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0

    Time frame: Approximately 30 months

  4. Objective Response Rate (ORR)

    Time frame: Approximately 24 months

  5. Best Overall Response (BOR)

    Time frame: Approximately 24 months

  6. Disease control rate (DCR)

    Time frame: Approximately 24 months

Secondary outcomes

  1. 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

  2. Progressionfree survival (PFS)

    Time frame: Approximately 24 months

  3. Overall survival (OS)

    Time frame: Approximately 30 months

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Qingshan Xue

CONTACT

[email protected]

+86 13332895357

Sponsors and collaborators

Lead sponsor

Shenzhen Majory Biotechnology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 19, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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