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

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: Pancreatic Ductal Adenocarcinoma (PDAC)
• Intervention / Treatment: Drug: Nab-paclitaxel; Drug: MR001; Drug: Irinotecan Liposome Injection combined with 5-FU/LV; Drug: Gemcitabine (GEM)

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

• Study Contact: Name: Qingshan Xue; Phone Number: +86 13332895357; Email: xueqs@majory.com.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 102218
      • Recruiting
      • Beijing Tsinghua Changgung Hospital
      • Contact: Jiahong Dong, MD, PhD; Phone Number: +86-10-56118899; Email: dongjiahong@mail.tsinghua.edu.cn
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Active, not recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Not yet recruiting
      • Harbin Medical University Cancer Hospital
      • Contact: Tongsen Zheng, PhD; Phone Number: +86 15134569619; Email: yqbfzhengtongsen@163.com
  • Jilin
    • Changchun, Jilin, China, 130015
      • Not yet recruiting
      • The First Hospital of Jilin University
      • Contact: Wei Li, PhD; Phone Number: +86 13756661267; Email: jdyylw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Nab-paclitaxel; Per locally approved formulation; Drug: MR001; Intravenous infusion; Drug: Irinotecan Liposome Injection combined with 5-FU/LV; Per locally approved formulation; Drug: Gemcitabine (GEM); Per locally approved formulation
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: Nab-paclitaxel; Per locally approved formulation; Drug: MR001; Intravenous infusion; 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: Nab-paclitaxel; Per locally approved formulation; Drug: MR001; Intravenous infusion; 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: Nab-paclitaxel; Per locally approved formulation; Drug: MR001; Intravenous infusion; 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)		Approximately 24 months
Number of participants who experience one or more dose-limiting toxicities (DLTs)		Approximately 12 months
Maximum Tolerated Dose (MTD) of MR001	The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules	Approximately 12 months
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	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)	Approximately 12 months
Progressionfree survival (PFS)	Approximately 24 months
Area Under the Plasma ConcentrationTime Curve (AUC) of MR001	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	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	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	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	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	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	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	Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)

Collaborators and Investigators

• Sponsor: Shenzhen Majory Biotechnology Co., Ltd.

Study record dates

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): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: PDAC; CD4; TGF-β1; MR001
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; 130-nm albumin-bound paclitaxel
• 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