MR001 plus chemotherapy for advanced or metastatic pancreatic ductal adenocarcinoma after first-line therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Tsinghua Changgung Hospital
  Beijing, Beijing Municipality, China Recruiting
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• Chongqing University Cancer Hospital
  Chongqing, Chongqing Municipality, China Not yet recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Not yet recruiting

Study contacts

• Study coordinator: Qingshan Xue
• Email: xueqs@majory.com.cn
• Phone: +86 13332895357

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.