Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antibodies

Immunoglobulins

On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg calculated based on the actual body weight

MRG003

Program Director, Master

Yuankai Shi, Doctor

The objective of this study is to assess the efficacy, safety of MRG003 as single agent in EGFR-positive advanced non-small cell lung cancer

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer

An Open-Label, Multi-Cohort, Multi-center, Non-Randomized, Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer

ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.

PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

TTR is defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation.

DCR is defined as the proportions of patients achieving CR, PR, and stable disease (SD) after treatment.

OS is defined as the duration from the start of treatment to death of any cause.

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.

Shanghai Miracogen Inc.

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Program Director

Wenhua Xue, Secretary

Qingxia Fan, Doctor

Baoxia He, Director

Ying Liu, Doctor

Fang Xu, Secretary

Xinjun Liang, Doctor

Xiaoran Zhang, Secretary

Meili Sun, Doctor

Zhehai Wang, Secretary

Changzheng Li, Doctor

Aiping Zhou, Doctor

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with EGFR-positive, HER2-negative, inoperable locally advanced or metastatic gastric cancer.

Approximately 6054 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003. Patients will receive 2.0 mg/kg dose of MRG003 intravenously every 3 weeks (Q3W) and may receive up to 24 months of MRG003 if there is evidence of clinical benefit to the patients.

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.

A Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in EGFR-Positive, HER2-Negative Advanced Gastric Cancer.

ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by Independent Review Committee (IRC) according to RECIST v1.1.

Area under the curve up to the last validated measurable plasma concentration

The proportion of patients with positive ADA immunogenicity results.

Phase Ia: MRG003 will be administrated by an IV infusion of escalating doses (0.1, 0.3, 0.6, 1.0, 2.0, 2.5, 3.0 mg/kg) on Day 1 of every 3 weeks (Q3W); Phase Ib: MRG003 will be administrated by an IV infusion of MTD/RP2D.

Ruihua Xu, M.D.

The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG003, as well as immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG003 in patients with advanced solid tumors, including colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma.

This study consists of two parts: Phase Ia dose escalation and Phase Ib dose expansion. The objective of Phase Ia is to determine MTD or RP2D, and Phase Ib is conducted to evaluate efficacy of MRG003 in patients with advanced colorectal cancer, squamous cell carcinoma of head and neck (SCCHN), and nasopharyngeal carcinoma.

A Study of MRG003 in Patients With Advanced Solid Tumors

An Open-Label, Dose-Finding, Phase I Study in Solid Tumors.

DLT is assessed on Day 21 (Day 1 to 21) of the first dose administration.

ORR was defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.

Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.

AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statics.

Blood samples for anti-drug antibody (ADA) analysis will be collected each time according to the pre-defined timepoints.

PFS was defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

DOR was defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

OS was defined as the duration from the start of treatment to death of any cause.

Incidence of AEs and serious adverse events (SAEs) will be assessed based on NCI-CTCAE v5.0

MRG003 will be administrated via intravenous infusion at 1.5, 2.0 mg/kg (MTD=2.5 mg/kg) once on Day 1 of every 3 weeks (21-day cycle).

HX008 will be administrated via intravenous infusion at 3 mg/kg once on Day 1 of every 3 weeks (21-day cycle).

MRG003+HX008

Yingrui Shi, M.D.

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in combination with HX008 in patients with EGFR-positive advanced or metastatic solid tumors.

This study consists of two parts: Phase I and Phase II. The objective of this study is to assess the safety and tolerability of MRG003 in combination with HX008 in patients with EGFR-positive advanced or metastatic solid tumors; and to explore the maximum tolerated dose (MTD) and to determine the recommended phase II dose (RP2D) of combination therapy; and to evaluate the preliminary efficacy, pharmacokinetics, and immunogenicity of combination therapy in the targeted study population.

A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors

An Open-label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MRG003 in Combination With HX008 in Patients With EGFR-positive Advanced Solid Tumors

MTD is the highest dose with the proportion of DLT less than 1/3

The dose level of MRG003 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.

DCR is defined as the proportion of subjects achieving CR, PR, and SD after treatment.

The proportion of patients with positive ADA results.

Adverse events that are difficult to deal with in clinical drug research

Plot of drug concentration changing with time after drug administration

Symptoms and General Pathology

Carcinoma, Squamous Cell

Recurrence

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Ye Guo, Doctor

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with recurrent or metastatic squamous cell carcinoma of head and neck.

The study consists of two stages. In Part A, approximately 22 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003. Based on the initial safety and efficacy data obtained from the Part A, the study design of second stage Part B single-arm study either will be continued or the trail will be terminated. If the Part A data support the continuation of the study, in the second stage, approximately an additional 98 patients will be enrolled to further evaluate the efficacy and safety of MRG003.

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

An Open-Label, Single Arm, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer	NCT04838548	Carcinoma, Non-...	MRG003	18 Years -	Shanghai Miracogen Inc.
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.	NCT05188209	Advanced or Met... Advanced or Met...	MRG003	18 Years - 75 Years	Shanghai Miracogen Inc.
A Study of MRG003 in Patients With Advanced Solid Tumors	NCT04868344	Advanced Solid ...	MRG003	18 Years -	Shanghai Miracogen Inc.
A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors	NCT05688605	Advanced Solid ...	MRG003+HX008	18 Years - 75 Years	Shanghai Miracogen Inc.
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck	NCT04868162	Recurrent or Me...	MRG003	18 Years -	Shanghai Miracogen Inc.
A Study of MRG003 in Patients With Advanced Solid Tumors	NCT04868344	Advanced Solid ...	MRG003	18 Years -	Shanghai Miracogen Inc.

Spots Global Cancer Trial Database for mrg003

Every month we try and update this database with for mrg003 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mrg003

Every month we try and update this database with for mrg003 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mrg003 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.