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
1 other identifier
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 19, 2025
CompletedStudy Start
First participant enrolled
December 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 22, 2028
December 31, 2025
December 1, 2025
2.5 years
November 14, 2025
December 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Disease control rate (DCR)
Approximately 24 months
Secondary Outcomes (11)
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
Overall survival (OS)
Approximately 30 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)
- +6 more secondary outcomes
Study Arms (7)
Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU
EXPERIMENTALMR001, 2mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration
Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU
EXPERIMENTALMR001, 4mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration
Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU
EXPERIMENTALMR001, 6mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration
Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine
EXPERIMENTALMR001, 2mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine
EXPERIMENTALMR001, 4mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine
EXPERIMENTALMR001, 6mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
Dose Expansion Part
EXPERIMENTALBased on the Dose escalation part results, the Investigator and Sponsor will determine one dose and dosing interval to proceed to the dose expansion study
Interventions
Intravenous infusion
Per locally approved formulation
Per locally approved formulation
Per locally approved formulation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 19, 2025
Study Start
December 24, 2025
Primary Completion (Estimated)
June 22, 2028
Study Completion (Estimated)
December 22, 2028
Last Updated
December 31, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share