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

NCT ID: NCT07138846

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-06-30

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.

Conditions

Advanced Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Arm

Interventions administered to this arm include MRG004A, which is the investigational drug product, plus best supportive care, including but not limited to pain management, nutrition support, and psychological therapy

Group Type: EXPERIMENTAL

MRG004A plus best supportive care

Intervention Type: DRUG

MRG004A will be administrated as specified in the protocol.

Control Arm

Placebo plus best supportive care, the definition of best supportive care is the same as that in the experiment arm

Group Type: PLACEBO_COMPARATOR

Placebo plus best supportive care

Intervention Type: DRUG

Placebo will be administrated as specified in the protocol, following the same dose regimen as MRG004A.

Interventions

MRG004A plus best supportive care

MRG004A will be administrated as specified in the protocol.

Intervention Type: DRUG

Placebo plus best supportive care

Placebo will be administrated as specified in the protocol, following the same dose regimen as MRG004A.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Miracogen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xianjun Yu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Program Director

Role: CONTACT

clinicaltrials@miracogen.com.cn

86-21-61637960

Facility Contacts

Xianjun Yu, M.D.

Role: primary

yuxianjun@fudanpci.org

86-21-64175590

Other Identifiers

MRG004A-002

Identifier Type: -

Identifier Source: org_study_id