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

Официальное название

A Randomized, Double-blind, Multi-center, Phase III Study of MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer

Обзор

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.

Вмешательства

• Препарат MRG004A plus best supportive care
  MRG004A will be administrated as specified in the protocol.
• Препарат Placebo plus best supportive care
  Placebo will be administrated as specified in the protocol, following the same dose regimen as MRG004A.

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: Baseline to study completion (up to 24 months)]

Вторичные конечные точки (7)

• Progression Free Survival (PFS) [Срок оценки: Baseline to study completion (up to 24 months)]
• Objective Response Rate (ORR) [Срок оценки: Baseline to study completion (up to 24 months)]
• Disease Control Rate (DCR) [Срок оценки: Baseline to study completion (up to 24 months)]
• Duration of Response (DOR) [Срок оценки: Baseline to study completion (up to 24 months)]
• Immunogenicity (ADA) [Срок оценки: Baseline to 14 days after the last dose.]
• Adverse Events (AEs) [Срок оценки: Baseline to 30 days after the last dose of study treatment]
• Serious Adverse Events (SAEs) [Срок оценки: Baseline to 30 days after the last dose of study treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07138846 · MRG004A-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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