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The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG006A in patients with advanced solid tumors.
This study consists of two parts. Phase I is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG006A. Phase II is a dose expansion study to further assess the efficacy, safety, pharmacokinetics and immunogenicityof MRG006A at confirmed RP2D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRG006A | Experimental | All patients in Phase I and Phase II will be administrated MRG006A on Day 1 of every 3 weeks (21-day cycle). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRG006A | Drug | Administrated intravenously |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) - Phase I | The highest dose confirmed wherein less than 2 out of 6, or < 33% of evaluable patients in a treatment cohort experiences dose-limiting toxicity (DLT). | Baseline to the end of the first treatment cycle (each cycle is 21 days). |
| Recommended Phase II Dose (RP2D) - Phase I | The dose level of MRG006A recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study. | Baseline to study completion (up to 24 months). |
| Adverse Events (AEs) - Phase I | 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) - Phase I | 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. |
| Objective Response Rate (ORR)- Phase II | ORR is defined as the proportion of subjects with CR and PR assessed by IRC and investigator according to RECIST v1.1 and mRECIST(HCC patients). And determine the objective response rate (CR + PR) and its 95% confidence interval. | Baseline to study completion (up to 24 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) - Phase I | ORR is defined as the proportion of subjects with CR and PR assessed by IRC and investigator according to RECIST v1.1 and mRECIST(HCC patients). And determine the objective response rate (CR + PR) and its 95% confidence interval. | Baseline to study completion (up to 24 months). |
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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 |
|---|---|---|
| Jian Zhou, M.D. | Fudan University | Principal Investigator |
| Hong Zhao, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Overall Survive (OS)- Phase II |
The time from start of study treatment to date of death as a result of any cause. |
| 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). |
| Disease Control Rate (DCR) | The proportion of patients who achieve CR, PR, or stable disease (SD) after treatment. | Baseline to study completion (up to 24 months). |
| Progression Free Survival (PFS) | The time from the date of first study dose to disease progression or death whichever occurs first. | Baseline to study completion (up to 24 months). |
| Cmax | Maximum observed blood concentration | Baseline to 30 days after the last dose of study treatment. |
| Tmax | Time to reach the maximum blood concentration. | Baseline to 30 days after the last dose of study treatment. |
| AUC0-t | Area under the blood concentration-time curve from time 0 to the time of last quantifiable concentration. | Baseline to 30 days after the last dose of study treatment. |
| Incidence of anti-drug antibody (ADA) | The proportion of patients with positive ADA results. | Baseline to 30 days after the last dose of study treatment. |
| QT interval corrected by Fridericia's formula(QTcF) | Evaluate the effect of MRG006A on the prolongation of QT interval corrected by heart rate using Fridericia's formula (QTcF) in patients with advanced solid tumors. | Baseline to 15 days after the third dose of study treatment. |
| Adverse Events (AEs) - Phase II | 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) - Phase II | 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. |
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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