MedDataX Logo

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

NCT ID: NCT07235202

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-24

Study Completion Date

2028-12-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

MR001 PDAC CD4 TGF-β1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

MR001

Intervention Type DRUG

Intravenous infusion

Irinotecan Liposome Injection combined with 5-FU/LV

Intervention Type DRUG

Per locally approved formulation

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

Group Type EXPERIMENTAL

MR001

Intervention Type DRUG

Intravenous infusion

Irinotecan Liposome Injection combined with 5-FU/LV

Intervention Type DRUG

Per locally approved formulation

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

Group Type EXPERIMENTAL

MR001

Intervention Type DRUG

Intravenous infusion

Irinotecan Liposome Injection combined with 5-FU/LV

Intervention Type DRUG

Per locally approved formulation

Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine

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

Group Type EXPERIMENTAL

MR001

Intervention Type DRUG

Intravenous infusion

Nab-paclitaxel

Intervention Type DRUG

Per locally approved formulation

Gemcitabine (GEM)

Intervention Type DRUG

Per locally approved formulation

Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine

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

Group Type EXPERIMENTAL

MR001

Intervention Type DRUG

Intravenous infusion

Nab-paclitaxel

Intervention Type DRUG

Per locally approved formulation

Gemcitabine (GEM)

Intervention Type DRUG

Per locally approved formulation

Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine

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

Group Type EXPERIMENTAL

MR001

Intervention Type DRUG

Intravenous infusion

Nab-paclitaxel

Intervention Type DRUG

Per locally approved formulation

Gemcitabine (GEM)

Intervention Type DRUG

Per locally approved formulation

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

Group Type EXPERIMENTAL

MR001

Intervention Type DRUG

Intravenous infusion

Irinotecan Liposome Injection combined with 5-FU/LV

Intervention Type DRUG

Per locally approved formulation

Nab-paclitaxel

Intervention Type DRUG

Per locally approved formulation

Gemcitabine (GEM)

Intervention Type DRUG

Per locally approved formulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MR001

Intravenous infusion

Intervention Type DRUG

Irinotecan Liposome Injection combined with 5-FU/LV

Per locally approved formulation

Intervention Type DRUG

Nab-paclitaxel

Per locally approved formulation

Intervention Type DRUG

Gemcitabine (GEM)

Per locally approved formulation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shenzhen Majory Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Qingshan Xue

Role: CONTACT

Phone: +86 13332895357

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jiahong Dong, MD, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MJR-MR001-02

Identifier Type: -

Identifier Source: org_study_id