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

NCT07235202 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-31

No results posted yet for this study

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.

Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

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

Sponsors & Collaborators

  • Shenzhen Majory Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-24
Primary Completion
2028-06-22
Completion
2028-12-22

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07235202 on ClinicalTrials.gov