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Hepatocellular CarcinomaPhase 1/2NCT07479485

MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II)

A Phase 1/2 study testing MRG006A, Pucotenlimab and Bevacizumab in people with Hepatocellular Carcinoma, run by Lepu Biopharma Co., Ltd. at 8 sites 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 is an open-label, multicenter, Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of MRG006A in combination with immune checkpoint inhibitors and targeted therapy in patients with advanced hepatocellular carcinoma (HCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
MRG006A, Pucotenlimab and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
8 sitesChina
Study dates
8 Apr 2026to Apr 2029
Phase
Phase 1/2
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

  • Able to understand and provide written informed consent, and comply with the requirements specified in the protocol.
  • Life expectancy ≥ 3 months.
  • Must provide tumor tissue specimens for GPC3 testing.
  • Histologically/cytologically confirmed hepatocellular carcinoma (HCC), Barcelona Clinic Liver Cancer (BCLC) Stage C or Stage B not amenable to curative surgery and/or locoregional therapy.
  • At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and modified RECIST (mRECIST).
  • No prior systemic antineoplastic therapy for unresectable HCC before first dose administration.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to first study drug administration.
  • Adequate organ function as specified.
  • Negative serum pregnancy test within 7 days prior to first dose (women of childbearing potential). Pregnant or lactating women are not eligible for this study.
  • Women of childbearing potential and male patients must agree to use adequate contraception during MRG006A treatment and for 180 days after the last infusion.

Who cannot join

  • Prior histologically/cytologically confirmed diagnosis of hepatocellular carcinoma with fibrolamellar, sarcomatoid, cholangiocarcinoma, or other components.
  • History of hepatic failure or hepatic encephalopathy, or history of liver transplantation.
  • Pleural effusion, ascites, or pelvic effusion, or clinically significant pericardial effusion.
  • Acute or chronic active hepatitis B or hepatitis C infection.
  • Central nervous system metastases.
  • Prior locoregional therapy for hepatocellular carcinoma within 4 weeks before first dose administration.
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  • Receipt of live attenuated vaccines within 4 weeks before first dose or planned administration during the study period.
  • Major surgical procedure within 4 weeks before first dose, or the presence of unhealed wounds, ulcers, or bone fractures.
  • Uncontrolled or poorly controlled medical conditions.
  • Toxicities from prior therapy that have not resolved to Grade 0 or 1 before first dose of study treatment.
  • Severe cardiac insufficiency or cerebrovascular events within 6 months prior, or occurrence of pulmonary embolism, deep vein thrombosis, gastrointestinal perforation and/or fistula, or intestinal obstruction.
  • Patients with double or multiple primary malignancies.
  • Hypersensitivity to any component or excipient of the investigational product.
  • Active or poorly controlled severe infection.
  • Any severe and/or uncontrolled systemic disease that, in the opinion of the investigator and sponsor, renders the patient unsuitable for participation in this study.

Trial locations and contacts

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

Program Director contact

86-21- 67680899

ra_bj@lepubiopharma.com

8 sites in 1 country

China8 sites, 8 recruiting

  • Beijing You An Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

    Jun Lv

    Not yet recruiting

  • The Ethics Committee of Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, Beijing Municipality, 100021

    Hong Zhao, 86-10-87787100, pumczhaohong@126.com

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Shunda Du

    Not yet recruiting

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350001

    Yongyi Zeng

    Not yet recruiting

  • Lishui Central Hospital

    Lishui, Zhejiang, 323000

    Jiansong Ji

    Not yet recruiting

  • The First Affiliated Hospital With Nanjing Medical University

    Nanjing, Jiangsu, 210006

    Xiangcheng Li

    Not yet recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality, 300308

    Huikai Li

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Jinxue Zhou

    Not yet recruiting

Other trials in China

About this study

Official title: An Open-Label, Multicenter, Phase I/II Study Evaluating MRG006A in Combination With Immune Checkpoint Inhibitors and Targeted Therapy in Patients With Advanced Hepatocellular Carcinoma

This is an open-label, multicenter, Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of MRG006A in combination with immune checkpoint inhibitors and targeted therapy in patients with advanced hepatocellular carcinoma (HCC).

Being tested
MRG006A, Pucotenlimab, Bevacizumab, PD1/VEGF antibody, TKI
Keywords
MRG006A, Pucotenlimab, Bevacizumab, TKI
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • MRG006ADrug

    Administrated intravenously

  • PucotenlimabDrug

    Administrated intravenously

  • BevacizumabDrug

    Administrated intravenously

  • PD1/VEGF antibodyDrug

    Administrated intravenously

  • TKIDrug

    Administrated intravenously

Study groups in NCT07479485
Study groupRoleWhat they receive
MRG006A+Pucotenlimab + BevacizumabExperimentalNot described
Receives: Drug: MRG006A; Drug: Pucotenlimab; Drug: Bevacizumab
MRG006A+ PD1/VEGF antibodyExperimentalNot described
Receives: Drug: MRG006A; Drug: PD1/VEGF antibody
MRG006A+ TKIExperimentalNot described
Receives: Drug: MRG006A; Drug: TKI

What is being measured

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

  1. Adverse events

    Proportion of participants experiencing treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Up to 2 years

  2. Recommended Phase 2 Dose

    Evaluate RP2D based on the safety and efficacy of different dosage cohorts.

    Measured: 1 year

Secondary outcomes (9)

  1. Peak concentration (Cmax)

    Cmax of ADC, TAb, free payload will be measured.

    Measured: Up to 2 years

  2. Time to peak (Tmax)

    Tmax of ADC, TAb, free payload will be measured.

    Measured: Up to 2 years

  3. Area under the concentration versus time curve (AUC)

    AUC of ADC, TAb, free payload will be measured.

    Measured: Up to 2 years

  4. Half-life time (t1/2)

    t1/2 of ADC, TAb, free payload will be measured.

    Measured: Up to 2 years

  5. Anti-Drug Antibody characteristics

    Proportion of subjects who develop treatment-emergent anti-drug antibody (ADA) positivity.

    Measured: Up to 2 years

  6. Objective Response Rate

    Proportion of patients with complete response/partial response assessed by Response Criteria in Solid Tumor version 1.1

    Measured: 6 months

  7. Disease Control Rate

    Proportion of patients with complete response/partial response and stable disease assessed by Response Criteria in Solid Tumor version 1.1

    Measured: 6 months

  8. Duration of Response

    The time from the first documentation of objective tumor response (CR or PR) until disease progression or death from any cause

    Measured: Up to 2 years

  9. Progression-Free Survival

    Time between the start of study treatment and progressive disease or any cause of death

    Measured: Up to 2 years

Timeline

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

  1. First posted18 Mar 2026
  2. Study start8 Apr 2026
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07479485
Sponsor's protocol ID
MRG006A-002
Status last verified
Jul 2026
First submitted
9 Mar 2026
Last updated
28 Jul 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 1/2 study testing MRG006A, Pucotenlimab and Bevacizumab in people with Hepatocellular Carcinoma, run by Lepu Biopharma Co., Ltd. at 8 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 10 inclusion and 15 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 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 combined 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.

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 Program Director (86-21- 67680899, ra_bj@lepubiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: Up to 2 years). 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 NCT07479485.

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 28 Jul 2026.

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