AzTrials
AzTrials

Hepato Cellular Carcinoma (HCC)Phase 2NCT07536789

Becotatug Vedotin (MRG003) in Previously Treated Advanced Hepatocellular Carcinoma

A Phase 2 study testing MRG003 in people with Hepato Cellular Carcinoma (HCC), run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study will evaluate the efficacy and safety of Becotatug vedotin, MRG003, in previously treated advanced hepatocellular carcinoma (HCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepato Cellular Carcinoma (HCC)
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
40 participants
Where
1 siteChina
Study dates
17 Apr 2026to 14 Apr 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Written informed consent obtained.
  • Age ≥ 18 years at time of study entry.
  • Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients.
  • Disease progression after ≥1 line of PD-1/L1 inhibitors-based regimens.
  • Archival or fresh biopsied tumor tissue samples obtained for immunohistochemistry (IHC) testing to determine EGFR protein.
  • At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1.
Show all 12Show fewer
  • Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).
  • Subjects with chronic HBV infection must have HBV DNA viral load < 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy.
  • Life expectancy of at least 12 weeks.
  • Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥60 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula)
  • Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.

Who cannot join

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  • Patients on a liver transplantation list or with advanced liver disease.
  • History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
  • Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
  • Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
  • Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
Show all 13Show fewer
  • Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.
  • Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to: a) history of interstitial lung disease b) Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection) c) known acute or chronic pancreatitis d) active tuberculosis e) any other active infection (viral, fungal or bacterial) requiring systemic therapy f) history of allogeneic tissue/solid organ transplant g) diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment. h) Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study. i) Live vaccine within 30 days prior to the first dose of treatment or during study treatment. j) History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS.
  • Medication that is known to interfere with any of the agents applied in the trial.
  • Any other efficacious cancer treatment except protocol specified treatment at study start.
  • Patient has received any other investigational product within 28 days of study entry.
  • Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). [Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Peng Wang, MD contact

8621-64041990

peng_wang@fudan.edu.cn

China1 site, 1 recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Peng Wang, MD, 8621-64041990, peng_wang@fudan.edu.cn

    Peng Wang, MD

    Recruiting

Other trials in China

About this study

Official title: Becotatug Vedotin (MRG003) in Previously Treated Advanced Hepatocellular Carcinoma: A Single-arm, Multi-cohort, Phase 2 Trial

This study will evaluate the efficacy and safety of Becotatug vedotin, MRG003, in previously treated advanced hepatocellular carcinoma (HCC).

Read the detailed description

Two cohorts will be recruited. Cohort 1 will recruit advanced HCC with EGFR expression 3+. Cohort 2 will recruit advanced HCC with EGFR expression 0-2+. Both cohorts will receive MRG003 monotherapy.

Being tested
MRG003

What participants receive

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

  • MRG003Drug

    MRG003 will be administered by IV, 2.3 mg/kg on day 1 of each 21 day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Study groups in NCT07536789
Study groupRoleWhat they receive
MRG003ExperimentalNot described
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) in Cohort 1.

    ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator.

    Measured: max 24 months

Secondary outcomes (8)

  1. Objective Response Rate (ORR) in Cohort 2.

    ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator.

    Measured: max 24 months

  2. Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

    DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD)

    Measured: max 24 months

  3. Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

    Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

    Measured: max 24 months

  4. Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

    TTR is defined as the time from the start of treatment until the first objective observation of a response (either partial response, PR, or complete response, CR), provided that the response is subsequently confirmed

    Measured: max 24 months

  5. Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

    PFS is defined as the time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first)

    Measured: max 24 months

  6. Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

    OS is defined as the time from study treatment to the date of death of the subject, regardless of the cause of death.

    Measured: max 42 months

  7. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.

    Measured: max 42 months

  8. Translational study

    Proportion of different immune cell types in tumors based on single-cell RNA sequencing between responders and non-responders.

    Measured: max 42 months

Timeline

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

  1. First posted17 Apr 2026
  2. Study start17 Apr 2026
  3. Primary completion15 Apr 2028 (estimated)
  4. Study completion14 Apr 2029 (estimated)

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07536789
Sponsor's protocol ID
B2026-005R
Status last verified
Apr 2026
First submitted
11 Apr 2026
Last updated
21 Apr 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 Hepato Cellular Carcinoma (HCC), run by Fudan University 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 12 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 21 Apr 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 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Peng Wang, MD (8621-64041990, peng_wang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) in Cohort 1. (time frame: max 24 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 NCT07536789.

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 21 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in