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

NCT07138846 | Not Yet Recruiting Phase 3

• 1 other identifier: MRG004A-002
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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

Keywords

MRG004A; Best Supportive Care; Placebo Controlled; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Progression Free Survival (PFS)

  Baseline to study completion (up to 24 months)

• Objective Response Rate (ORR)

  Baseline to study completion (up to 24 months)

• Disease Control Rate (DCR)

  Baseline to study completion (up to 24 months)

• Duration of Response (DOR)

  Baseline to study completion (up to 24 months)

• Immunogenicity (ADA)

  Baseline to 14 days after the last dose.

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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

Control Arm

PLACEBO COMPARATOR

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

Interventions

MRG004A plus best supportive care DRUG

MRG004A will be administrated as specified in the protocol.

Experimental Arm

Placebo plus best supportive care DRUG

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

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Xianjun Yu, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

86-21-61637960; clinicaltrials@miracogen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)