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CompletedNCT04868344Updated Aug 31, 2026

A Study of MRG003 in Patients With Advanced Solid Tumors

A Phase 1 interventional study of MRG003 in Advanced Solid Tumors, sponsored by Lepu Biopharma Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Lepu Biopharma Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled May 2018, registered Apr 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Advanced Solid Tumors

Keywords

  • MRG003
  • Antibody Drug Conjugate (ADC)
  • Solid tumors
03

In context

Lead sponsor

Lepu Biopharma Co., Ltd. is the lead sponsor of 16 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • 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

Interventions

  • DrugMRG003

    Administered intravenously

06

What researchers measure

Primary outcomes

  1. Dose Limiting Toxicity (DLT) - Phase Ia

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

    Time frame: 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.

    Time frame: Baseline to study completion (up to 24 weeks)

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

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

07

Study locations

1 site
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04868344
Lead sponsor
Lepu Biopharma Co., Ltd.
Responsible party
Sponsor
First posted
Apr 30, 2021
Start date
May 9, 2018
Primary completion
Mar 29, 2021
Completion
Mar 29, 2021
Last update
Aug 31, 2026

Study contacts

Ruihua Xu, M.D.
principal investigator · Sun Yat-Sen University Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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