A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer
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.
You may not be if
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
Clareo Health | A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer
