A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLepu Biopharma Co., Ltd.

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

Treatment groups

231 Participants
are divided into 2 treatment groups

Sponsors and collaborators