AzTrials
AzTrials

Advanced or Metastatic Biliary Tract CancerPhase 2NCT04838964

A Study of MRG003 in the Treatment of EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer

A Phase 2 study testing MRG003 in people with Advanced or Metastatic Biliary Tract Cancer, run by Lepu Biopharma Co., Ltd. at 7 sites in China.

Completed

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

Official record
Search all trials

Trial summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 as single agent in EGFR-positive unresectable locally advanced or metastatic biliary tract cancer patients who have progressed during or relapsed after at least one prior standard therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
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
15 participants
Where
7 sitesChina
Study dates
18 May 2021to 20 Oct 2022
Phase
Phase 2
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 to 75 years
  • 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.
  • Aged 18 to 75 (including 18 and 75), both genders.
  • Expected survival time ≥ 12 weeks.
  • Patients with unresectable locally advanced or metastatic biliary tract cancer confirmed by histopathology.
  • Failed in the prior one or more standard therapies.
  • EGFR positive in the tumor specimens confirmed by central laboratory test.
Show all 14Show fewer
  • Archival or biopsy tumor specimens should be provided (primary or metastatic).
  • Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
  • ECOG performance score 0 or 1.
  • Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia, non-clinically significant or asymptomatic laboratory abnormalities).
  • No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.
  • Organ function must meet the basic requirements.
  • Coagulation function must meet the basic requirements.
  • Patients of childbearing potential must take effective contraceptive measures during the treatment and for 6 months after the last dose of treatment.

Who cannot join

  • History of hypersensitivity to any component of MRG003.
  • Received chemotherapy, radiotherapy, biologicals, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first dose.
  • Presence of clinical manifestation of biliary obstruction.
  • Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage.
  • Presence of central nervous system (CNS) metastasis and/or neoplastic meningitis.
  • Any severe or uncontrolled systemic diseases.
Show all 18Show fewer
  • Patients with poorly controlled heart diseases.
  • Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection.
  • History of other primary malignancies.
  • History of the following ophthalmologic abnormalities：severe dry eye syndrome; keratoconjunctivitis sicca; severe exposure keratitis; any other condition that may increase the risk of corneal epithelial damage.
  • History of severe skin disease or chronic skin disease requiring oral or intravenous treatment.
  • History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
  • Peripheral neuropathy greater than Grade 1.
  • Patients with active autoimmune disease or a history of autoimmune disease, who are using immunosuppressive agents, or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.
  • History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C).
  • Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials.
  • Female patents with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.
  • Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100000

  • Beijing Youan Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100007

  • Bethune First Hospital of Jilin University

    Changchun, Jilin, 130061

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG003 in the Treatment of Patients With EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 as single agent in EGFR-positive unresectable locally advanced or metastatic biliary tract cancer patients who have progressed during or relapsed after at least one prior standard therapy.

Read the detailed description

The study consists of two stages. In Phase IIa, approximately 25 subjects will be enrolled to evaluate the safety and preliminarily efficacy of MRG003. Based on the safety and efficacy data obtained from the Phase IIa, the study design of the second stage Phase IIb single-arm study either will be adjusted or the trial will be stopped. If the initial Phase IIa data support the continuation of the study, in the second stage, approximately an additional 55 subjects will be enrolled to further evaluate the efficacy and safety of MRG003.

Being tested
MRG003
Keywords
MRG003, Antibody Drug Conjugate (ADC), EGFR, Biliary Tract Cancer
Medical subject headings
Biliary Tract Neoplasms

What participants receive

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

  • MRG003Drug

    Administrated intravenously

Study groups in NCT04838964
Study groupRoleWhat they receive
MRG003ExperimentalMRG003 will be administrated via IV infusion at 2.0 mg/kg on Day 1 of every 3 weeks (21-day cycle).
Receives: Drug: MRG003

What is being measured

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

  1. Objective Response Rate (ORR) by Independent Review Committee (IRC)

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

    Measured: Baseline to study completion, up to 12 months

Secondary outcomes (9)

  1. ORR by Investigator

    ORR is defined as the percentage of patients with a CR and PR as assessed by Investigator according to RECIST v1.1.

    Measured: Baseline to study completion, up to 12 months

  2. Duration of Response (DoR)

    DOR is defined as the time from first documented objective response to the first onset of tumor progression or death of any cause.

    Measured: Baseline to study completion, up to 12 months

  3. Time to Response (TTR)

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

    Measured: Baseline to study completion, up to 12 months

  4. Disease Control Rate (DCR)

    DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment.

    Measured: Baseline to study completion, up to 12 months

  5. Progression Free Survival (PFS)

    PFS is 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 12 months

  6. Overall Survival (OS)

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

    Measured: Baseline to study completion, up to 12 months

  7. Adverse Events (AEs)

    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.

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

  8. Pharmacokinetics (PK) parameter of MRG003: concentration-time curve

    Concentration-time curve will be depicted based on pharmacokinetics concentration set (PKCS).

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

  9. Incidence of anti-drug antibody (ADA)

    The incidence of ADA analysis will be summarized for all patients who received at least one cycle study treatment.

    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 posted9 Apr 2021
  2. Study start18 May 2021
  3. Primary completion20 Oct 2022
  4. Study completion20 Oct 2022

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04838964
Sponsor's protocol ID
MRG003-003
Status last verified
Sep 2026
First submitted
6 Apr 2021
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MRG003 in people with Advanced or Metastatic Biliary Tract Cancer, run by Lepu Biopharma Co., Ltd. at 7 sites 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 14 inclusion and 18 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Objective Response Rate (ORR) by Independent Review Committee (IRC) (time frame: Baseline to study completion, up to 12 months). 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 NCT04838964.

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 9 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in