MR001 plus chemotherapy for advanced or metastatic pancreatic ductal adenocarcinoma after first-line therapy
An Open-label, Dose-escalation and Dose-expansion Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MR001 in Combination With Standard Chemotherapy Regimens in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Who Have Progressed After First-line Therapy
This trial will test whether adding MR001 to standard chemotherapy helps people with locally advanced or metastatic pancreatic ductal adenocarcinoma whose disease progressed after first-line therapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shenzhen Majory Biotechnology Co., Ltd. Industry-sponsored |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07235202 on ClinicalTrials.gov |
What this trial studies
This open-label Phase Ib/IIa study uses a dose-escalation followed by dose-expansion design to test the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 given with standard chemotherapy in patients with locally advanced or metastatic PDAC who progressed after one prior systemic regimen. MR001, a monoclonal antibody directed at pathways related to CD4/TGF-β1 signaling, is administered in combination with standard regimens including irinotecan liposome plus 5-FU/LV, nab-paclitaxel, or gemcitabine. Primary endpoints focus on safety, tolerability, and pharmacokinetics during dose escalation, with expansion cohorts assessing preliminary anti-tumor activity by RECIST v1.1 and exploratory biomarker analyses. The trial is sponsored by Shenzhen Majory Biotechnology and conducted at Beijing Tsinghua Changgung Hospital.
Who should consider this trial
Good fit: Adults with histologically confirmed locally advanced or metastatic PDAC who progressed after exactly one prior systemic therapy, have ECOG 0–1, measurable disease, and adequate organ function would be eligible.
Not a fit: Patients with uncontrolled brain metastases, significant organ dysfunction, recent systemic immunosuppression, pregnancy, or known hypersensitivity to MR001 are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding MR001 could improve disease control and survival for patients with PDAC who have limited options after first-line therapy.
How similar studies have performed: Combining immunomodulatory antibodies with chemotherapy in PDAC is relatively novel and while preclinical data and limited early-phase clinical work suggest potential, there is not yet established proof of major clinical benefit in this setting.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qingshan Xue
- Email: xueqs@majory.com.cn
- Phone: +86 13332895357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.