A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo And Best Supportive Care In The Treatment Of Patients With Advanced Pancreatic Cancer

Study Overview

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

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.

N/A

Advanced Pancreatic Cancer

DRUG: MRG004A plus best supportive care
DRUG: Placebo plus best supportive care

MRG004A-002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-08-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-17
First Submitted that Met QC Criteria 2025-08-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-24
First Posted (ACTUAL) 2025-08-24	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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	DRUG: MRG004A plus best supportive care MRG004A will be administrated as specified in the protocol.
PLACEBO_COMPARATOR: Control Arm Placebo plus best supportive care, the definition of best supportive care is the same as that in the experiment arm	DRUG: Placebo plus best supportive care Placebo will be administrated as specified in the protocol, following the same dose regimen as MRG004A.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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

DRUG: MRG004A plus best supportive care

MRG004A will be administrated as specified in the protocol.

PLACEBO_COMPARATOR: Control Arm

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

DRUG: Placebo plus best supportive care

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

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the duration from the start of treatment to death of any cause.	Baseline to study completion (up to 24 months)

Secondary Outcome Measures	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.	Baseline to study completion (up to 24 months)
Objective Response Rate (ORR)	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.	Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)	DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.	Baseline to study completion (up to 24 months)
Duration of Response (DOR)	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.	Baseline to study completion (up to 24 months)
Immunogenicity (ADA)	The proportion of patients with positive ADA results.	Baseline to 14 days after the last dose.
Adverse Events (AEs)	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.	Baseline to 30 days after the last dose of study treatment
Serious Adverse Events (SAEs)	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	Baseline to 30 days after the last dose of study treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Program Director

Phone Number: 86-21-61637960

Email: clinicaltrials@miracogen.com.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Xianjun Yu, M.D., Fudan University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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