About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- MRG004A plus best supportive care
- Placebo plus best supportive care