NCT07235202 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 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Majory Biotechnology Co., Ltd. |
| Condition | Pancreatic Ductal Adenocarcinoma (PDAC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-12-24 |
| Primary Completion | 2028-06-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2025-12-24 with a primary completion date of 2028-06-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07235202 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Ductal Adenocarcinoma (PDAC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07235202 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07235202 currently recruiting?
Yes, NCT07235202 is actively recruiting participants. Contact the research team at xueqs@majory.com.cn for enrollment information.
Where is the NCT07235202 trial being conducted?
This trial is being conducted at Beijing, China, Chongqing, China, Fuzhou, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT07235202 clinical trial?
NCT07235202 is sponsored by Shenzhen Majory Biotechnology Co., Ltd.. The trial plans to enroll 45 participants.