- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04868344
A Study of MRG003 in Patients With Advanced Solid Tumors
April 29, 2021 updated by: Shanghai Miracogen Inc.
An Open-Label, Dose-Finding, Phase I Study in Solid Tumors.
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Willing to sign the ICF and follow the requirements specified in the protocol.
- Age: ≥18 years and ≤75 years, both genders
- Expected survival time≥12 weeks
- Phase Ia: Patients with histologically and cytologically confirmed advanced or metastatic solid tumor
- Phase Ib: Patients with histologically and cytologically confirmed EGFR-positive advanced or metastatic colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma
- Subjects must have measurable lesions according to the response Evaluation Criteria In Solid Tumors(RECIST v1.1)
- ECOG performance score 0 or 1
- Acceptable liver, renal, and hematologic function
- 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 hypersensitivity to any component of the investigational product
- Presence of central nervous system metastasis
- Prior history of other primary malignancies
- Known history of clinically significant hepatic diseases
- Evidence of active infection of human immunodeficiency virus (HIV)
- History of ophthalmic abnormalities
- Any severe or uncontrolled systemic disease judged by the investigator
- Patients with poorly controlled heart diseases
- Received radiotherapy, chemotherapy, biotherapy, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment
- Major surgery or surgical therapy for any cause within 4 weeks prior to the first dose of investigational drug
- Planned surgery or surgery is the best interest of patients as determined by investigator
- History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy
- Active concomitant diseases that might increase risks of toxicity
- Pregnancy, or breast feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MRG003
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.
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Administered intravenously
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Limiting Toxicity (DLT) - Phase Ia
Time Frame: First cycle (21 days)
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DLT is assessed on Day 21 (Day 1 to 21) of the first dose administration.
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First cycle (21 days)
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Objective Response Rate (ORR) - Phase Ib
Time Frame: Baseline to study completion (up to 24 weeks)
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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.
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Baseline to study completion (up to 24 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK parameter for MRG003: Maximum Drug Concentration (Cmax)
Time Frame: Baseline to study completion (up to 24 weeks)
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Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.
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Baseline to study completion (up to 24 weeks)
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PK parameter for MRG003: Area Under the Curve Up to the Last Validated Measurable Plasma Concentration (AUClast)
Time Frame: Baseline to study completion (up to 24 weeks)
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AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statics.
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Baseline to study completion (up to 24 weeks)
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PK parameter for total antibody (TAb): Cmax
Time Frame: Baseline to study completion (up to 24 weeks)
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Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.
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Baseline to study completion (up to 24 weeks)
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PK parameter for TAb: AUClast
Time Frame: Baseline to study completion (up to 24 weeks)
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AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statics.
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Baseline to study completion (up to 24 weeks)
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PK parameter for Monomethyl Auristatin E (MMAE): Cmax
Time Frame: Baseline to study completion (up to 24 weeks)
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Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.
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Baseline to study completion (up to 24 weeks)
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PK parameter for MMAE: AUClast
Time Frame: Baseline to study completion (up to 24 weeks)
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AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statics.
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Baseline to study completion (up to 24 weeks)
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Immunogenicity
Time Frame: Baseline to study completion (up to 24 weeks)
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Blood samples for anti-drug antibody (ADA) analysis will be collected each time according to the pre-defined timepoints.
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Baseline to study completion (up to 24 weeks)
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Progression Free Survival (PFS) - Phase Ib only
Time Frame: Baseline to study completion (up to 24 weeks)
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PFS was defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
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Baseline to study completion (up to 24 weeks)
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Duration of Response (DoR) - Phase Ib only
Time Frame: Baseline to study completion (up to 24 weeks)
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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.
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Baseline to study completion (up to 24 weeks)
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Overall Survival (OS) - Phase Ib only
Time Frame: Baseline to study completion (up to 24 weeks)
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OS was defined as the duration from the start of treatment to death of any cause.
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Baseline to study completion (up to 24 weeks)
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Incidence of Adverse Events (AEs)
Time Frame: Baseline to 30 days after the last dose of study treatment
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Incidence of AEs and serious adverse events (SAEs) will be assessed based on NCI-CTCAE v5.0
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Baseline to 30 days after the last dose of study treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 9, 2018
Primary Completion (ACTUAL)
March 29, 2021
Study Completion (ACTUAL)
March 29, 2021
Study Registration Dates
First Submitted
April 29, 2021
First Submitted That Met QC Criteria
April 29, 2021
First Posted (ACTUAL)
April 30, 2021
Study Record Updates
Last Update Posted (ACTUAL)
April 30, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRG003-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on MRG003
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Shanghai Miracogen Inc.RecruitingRecurrent or Metastatic Squamous Cell Carcinoma of Head and NeckChina
-
Shanghai Miracogen Inc.RecruitingAdvanced or Metastatic Gastric Cancer | Advanced or Metastatic Gastroesophageal Junction CarcinomaChina
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Shanghai Miracogen Inc.RecruitingCarcinoma, Non-Small-Cell LungChina
-
Shanghai Miracogen Inc.RecruitingAdvanced or Metastatic Biliary Tract CancerChina
-
Shanghai Miracogen Inc.RecruitingAdvanced Solid TumorsChina
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Shanghai Miracogen Inc.RecruitingRecurrent or Metastatic Nasopharyngeal CarcinomaChina
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Shanghai Miracogen Inc.Not yet recruitingSquamous Cell Carcinoma of the Head and NeckChina