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

Shanghai Miracogen

Status and phase: Not yet enrolling; Phase 3

Conditions: Advanced Pancreatic Cancer

Treatments: Drug: MRG004A plus best supportive care; Drug: Placebo plus best supportive care

Study type: Interventional

Funder types: Industry

Identifiers

NCT07138846

MRG004A-002

Details and patient eligibility

About

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.

Enrollment: 231 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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231 participants in 2 patient groups, including a placebo group

Experimental Arm

Experimental group

Description:

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

Treatment:

Drug: MRG004A plus best supportive care

Control Arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo plus best supportive care