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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control Arm | Placebo Comparator | Placebo plus best supportive care, the definition of best supportive care is the same as that in the experiment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRG004A plus best supportive care | Drug | MRG004A will be administrated as specified in the protocol. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Program Director | Contact | 86-21-61637960 | clinicaltrials@miracogen.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xianjun Yu, M.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
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| Placebo plus best supportive care | Drug | Placebo will be administrated as specified in the protocol, following the same dose regimen as MRG004A. |
|
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 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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