Not yet recruiting NCT07138846
A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRG004A plus best supportive care, Placebo plus best supportive care.
- Who it may be relevant to
- Registry conditions: Advanced Pancreatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug MRG004A plus best supportive care
MRG004A will be administrated as specified in the protocol. - 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
- Overall Survival (OS) [Time frame: Baseline to study completion (up to 24 months)]
Secondary outcome measures (7)
- Progression Free Survival (PFS) [Time frame: Baseline to study completion (up to 24 months)]
- Objective Response Rate (ORR) [Time frame: Baseline to study completion (up to 24 months)]
- Disease Control Rate (DCR) [Time frame: Baseline to study completion (up to 24 months)]
- Duration of Response (DOR) [Time frame: Baseline to study completion (up to 24 months)]
- Immunogenicity (ADA) [Time frame: Baseline to 14 days after the last dose.]
- Adverse Events (AEs) [Time frame: Baseline to 30 days after the last dose of study treatment]
- Serious Adverse Events (SAEs) [Time frame: Baseline to 30 days after the last dose of study treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07138846 · MRG004A-002