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Advanced Solid TumorsPhase 1NCT04868344

A Study of MRG003 in Patients With Advanced Solid Tumors

A Phase 1 study testing MRG003 in people with Advanced Solid Tumors, run by Lepu Biopharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
MRG003
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteChina
Study dates
9 May 2018to 29 Mar 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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）
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
MRG003
Keywords
MRG003, Antibody Drug Conjugate (ADC), Solid tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRG003Drug

    Administered intravenously

Study groups in NCT04868344
Study groupRoleWhat they receive
MRG003ExperimentalPhase 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.
Receives: Drug: MRG003

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity (DLT) - Phase Ia

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

    Measured: First cycle (21 days)

  2. Objective Response Rate (ORR) - Phase Ib

    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.

    Measured: Baseline to study completion (up to 24 weeks)

Secondary outcomes (11)

  1. PK parameter for MRG003: Maximum Drug Concentration (Cmax)

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

    Measured: Baseline to study completion (up to 24 weeks)

  2. PK parameter for MRG003: Area Under the Curve Up to the Last Validated Measurable Plasma Concentration (AUClast)

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

    Measured: Baseline to study completion (up to 24 weeks)

  3. PK parameter for total antibody (TAb): Cmax

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

    Measured: Baseline to study completion (up to 24 weeks)

  4. PK parameter for TAb: AUClast

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

    Measured: Baseline to study completion (up to 24 weeks)

  5. PK parameter for Monomethyl Auristatin E (MMAE): Cmax

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

    Measured: Baseline to study completion (up to 24 weeks)

  6. PK parameter for MMAE: AUClast

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

    Measured: Baseline to study completion (up to 24 weeks)

  7. Immunogenicity

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

    Measured: Baseline to study completion (up to 24 weeks)

  8. Progression Free Survival (PFS) - Phase Ib only

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

    Measured: Baseline to study completion (up to 24 weeks)

  9. Duration of Response (DoR) - Phase Ib only

    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.

    Measured: Baseline to study completion (up to 24 weeks)

  10. Overall Survival (OS) - Phase Ib only

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

    Measured: Baseline to study completion (up to 24 weeks)

  11. Incidence of Adverse Events (AEs)

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

    Measured: Baseline to 30 days after the last dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2021
  2. Study start9 May 2018
  3. Primary completion29 Mar 2021
  4. Study completion29 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04868344
Sponsor's protocol ID
MRG003-001
Status last verified
Aug 2026
First submitted
29 Apr 2021
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Qiu MZ, Zhang Y, Guo Y, Guo W, Nian W, Liao W, Xu Z, Zhang W, Zhao HY, Wei X, Xue L, Tang W, Wu Y, Ren G, Wang L, Xi J, Jin Y, Li H, Hu C, Xu RH. Evaluation of Safety of Treatment With Anti-Epidermal Growth Factor Receptor Antibody Drug Conjugate MRG003 in Patients With Advanced Solid Tumors: A Phase 1 Nonrandomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1042-1046. doi: 10.1001/jamaoncol.2022.0503.

    PubMed 35511148

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MRG003 in people with Advanced Solid Tumors, run by Lepu Biopharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) - Phase Ia (time frame: First cycle (21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04868344, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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