A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancr… (NCT07235202) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy
China45 participantsStarted 2025-12-24
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Timeframe: Approximately 12 months
2
Maximum Tolerated Dose (MTD) of MR001
Timeframe: Approximately 12 months
3
Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0