Status:
NOT_YET_RECRUITING
A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer
Lead Sponsor:
Shanghai Miracogen Inc.
Conditions:
Advanced Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, multi-center, phase III study to evaluate the efficacy and safety, pharmacokinetic profile and immunogenicity of MRG004A in patients with advanced pancreatic cancer...
Eligibility Criteria
Inclusion
- Willing to sign the informed consent form and follow the requirements specified in the protocol.
- Patients with histologically and cytologically confirmed locally advanced or metastatic pancreatic cancer, including adenocarcinoma, who have failed at least prior systemic therapies including gemcitabine and fluorouracil.
- Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- The score of ECOG for performance status is 0 to 2.
- Organ functions and coagulation function must meet the basic requirements.
- Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
Exclusion
- History of other primary malignant tumors
- Active metastasis to brain or meninges
- Active acute or chronic inflammatory skin disease, history of Steven-Johnson syndromes
- History of active or chronic corneal and conjunctival diseases, or other clinically significant ocular diseases that affect the ophthalmic monitoring of the investigational drug
- Received certain anti-tumor therapies or strong CYP3A4 inhibitors and have not complete the wash-out period, or have not fully recovered from major surgery
- AEs due to prior anti-tumor therapy(ies) that have not resolved to ≤Grade 1 per CTCAE v5.0
- Presence of ≥Grade 2 peripheral neuropathy per CTCAE v5.0
- Poorly controlled pleural and peritoneal effusion or pericardial effusion
- Severe cardiac dysfunction within 6 months before enrollment
- History of ventricular tachycardia, or torsade des pointes
- Uncontrolled or poorly controlled hypertension
- Compression fractures of the spine that have not been treated with surgery and/or radiation therapy, or have not been stable within 2 weeks before randomization
- Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
- Patients with high risk of bleeding per investigator's judgement.
- Patients who have active infection including but not limited to hepatitis B, hepatitis C, AIDS, or syphilis.
- Active uncontrolled bacterial, viral, fungal, rickettsial, or parasitic infection.
- Moderate to severe dyspnea at rest, severe primary lung disease, interstitial lung disease, or pneumonia.
- Uncontrolled pain due to cancer
- Active or history of autoimmune disease that requiring systemic hormone therapy
- History of hypersensitivity to any component of the investigational product.
- Other situations that are not suitable to participate a clinical trial per investigator's judgement
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT07138846
Start Date
January 1 2026
End Date
June 1 2027
Last Update
August 24 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032