Actively Recruiting
An Open-label, Dose-escalation and Dose-expansion Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MR001 Combined With Standard Chemotherapy Regimens in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Who Have Progressed After First-line Therapy
Led by Shenzhen Majory Biotechnology Co., Ltd. · Updated on 2026-05-26
45
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and early effects of a drug called MR001 combined with standard chemotherapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have worsened after their first treatment. This Phase Ib/IIa open-label study aims to understand how well MR001 works and how safe it is when given with chemotherapy to this patient group. The study involves giving MR001 intravenously once a week at different doses (2mg/kg, 4mg/kg, or 6mg/kg) combined with either Irinotecan Liposome plus leucovorin/5-FU or nab-paclitaxel plus gemcitabine, following approved local dosing guidelines. Initially, patients participate in a dose-escalation phase to find the best dose and schedule, followed by a dose-expansion phase to further evaluate the chosen dose combination based on earlier results. Participants will be monitored over several months with assessments including tracking side effects, measuring drug levels in the blood, and evaluating tumor response using recognized criteria. The study will measure outcomes such as dose-limiting toxicities, maximum tolerated dose, response rates, progression-free survival, and overall survival. Blood tests will also assess immune system markers. The total monitoring period spans up to about 30 months, with safety and effectiveness evaluations throughout the study.
CONDITIONS
Brief 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 pancreatic ductal adenocarcinoma (PDAC) with progression after only one prior systemic therapy.
- At least one measurable tumor lesion according to RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Life expectancy greater than 3 months.
- Adequate organ and bone marrow function as shown by laboratory tests.
- Ability to voluntarily sign the informed consent form.
You will not qualify if you...
- Known allergy or hypersensitivity to MR001 or similar monoclonal antibodies.
- Need for systemic immunosuppressive therapy within 14 days before starting study treatment.
- Uncontrolled active infections or other active cancers.
- Uncontrolled or inadequately controlled brain metastases or leptomeningeal metastasis.
- Significant heart, kidney, or liver disease.
- Pregnant or breastfeeding women.
- Any other condition that the investigator believes may increase risk or interfere with study results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 months
Participants receive MR001 combined with standard chemotherapy regimens administered intravenously according to their assigned dose group.
Weekly visits for dosing and assessments during treatment cycles
Duration - Up to approximately 18 months
Participants are monitored for safety, efficacy, and long-term outcomes after treatment ends.
Regular visits at designated timepoints for pharmacokinetics and safety assessments
Trial Site Locations
Total: 4 locations
1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Actively Recruiting
2
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Active, Not Recruiting
3
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
4
The First Hospital of Jilin University
Changchun, Jilin, China, 130015
Not Yet Recruiting
Research Team
Q
Qingshan Xue
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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