Actively Recruiting
A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy
Led by Shenzhen Majory Biotechnology Co., Ltd. · Updated on 2025-12-31
45
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 greater than 3 months.
- Adequate organ and marrow function as defined by laboratory parameters.
- Voluntarily sign the informed consent form.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Actively Recruiting
Research Team
Q
Qingshan Xue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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