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

Not Applicable

Not yet recruiting

• Conditions: Advanced Pancreatic Cancer
• Interventions: Drug: MRG004A plus best supportive care; Drug: Placebo plus best supportive care

• Registration Number: NCT07138846
• Lead Sponsor: Shanghai Miracogen Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-17
• Study First Submitted QC: 2025-08-17
• Last Update Submitted: 2025-08-17
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-24
• Study Start: 2026-01-01
• Primary Completion: 2027-06
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 231

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	MRG004A plus best supportive care	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
Control Arm	Placebo plus best supportive care	Placebo plus best supportive care, the definition of best supportive care is the same as that in the experiment arm

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Baseline to study completion (up to 24 months)	OS is defined as the duration from the start of treatment to death of any cause.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Baseline to study completion (up to 24 months)	PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Objective Response Rate (ORR)	Baseline to study completion (up to 24 months)	ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.
Disease Control Rate (DCR)	Baseline to study completion (up to 24 months)	DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
Duration of Response (DOR)	Baseline to study completion (up to 24 months)	The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier.
Immunogenicity (ADA)	Baseline to 14 days after the last dose.	The proportion of patients with positive ADA results.
Adverse Events (AEs)	Baseline to 30 days after the last dose of study treatment	Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
Serious Adverse Events (SAEs)	Baseline to 30 days after the last dose of study treatment	Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China