A Study of MRG003 in Patients With Advanced Solid Tumors

August 26, 2026 updated by: Lepu Biopharma Co., Ltd.

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: MRG003
Administered intravenously

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicity (DLT) - Phase Ia
Time Frame: First cycle (21 days)
DLT is assessed on Day 21 (Day 1 to 21) of the first dose administration.
First cycle (21 days)
Objective Response Rate (ORR) - Phase Ib
Time Frame: Baseline to study completion (up to 24 weeks)
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.
Baseline to study completion (up to 24 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PK parameter for MRG003: Maximum Drug Concentration (Cmax)
Time Frame: Baseline to study completion (up to 24 weeks)
Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.
Baseline to study completion (up to 24 weeks)
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)
AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statics.
Baseline to study completion (up to 24 weeks)
PK parameter for total antibody (TAb): Cmax
Time Frame: Baseline to study completion (up to 24 weeks)
Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.
Baseline to study completion (up to 24 weeks)
PK parameter for TAb: AUClast
Time Frame: Baseline to study completion (up to 24 weeks)
AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statics.
Baseline to study completion (up to 24 weeks)
PK parameter for Monomethyl Auristatin E (MMAE): Cmax
Time Frame: Baseline to study completion (up to 24 weeks)
Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.
Baseline to study completion (up to 24 weeks)
PK parameter for MMAE: AUClast
Time Frame: Baseline to study completion (up to 24 weeks)
AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statics.
Baseline to study completion (up to 24 weeks)
Immunogenicity
Time Frame: Baseline to study completion (up to 24 weeks)
Blood samples for anti-drug antibody (ADA) analysis will be collected each time according to the pre-defined timepoints.
Baseline to study completion (up to 24 weeks)
Progression Free Survival (PFS) - Phase Ib only
Time Frame: Baseline to study completion (up to 24 weeks)
PFS was 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 weeks)
Duration of Response (DoR) - Phase Ib only
Time Frame: Baseline to study completion (up to 24 weeks)
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.
Baseline to study completion (up to 24 weeks)
Overall Survival (OS) - Phase Ib only
Time Frame: Baseline to study completion (up to 24 weeks)
OS was defined as the duration from the start of treatment to death of any cause.
Baseline to study completion (up to 24 weeks)
Incidence of Adverse Events (AEs)
Time Frame: Baseline to 30 days after the last dose of study treatment
Incidence of AEs and serious adverse events (SAEs) will be assessed based on NCI-CTCAE v5.0
Baseline to 30 days after the last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lepu Biopharma Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ruihua Xu, M.D., Sun Yat-Sen University Cancer Center

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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