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Recruiting NCT07479485

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

Phase I / Phase II Interventional Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRG006A, Pucotenlimab, Bevacizumab, PD1/VEGF antibody.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

  • Drug MRG006A
    Administrated intravenously
  • Drug Pucotenlimab
    Administrated intravenously
  • Drug Bevacizumab
    Administrated intravenously
  • Drug PD1/VEGF antibody
    Administrated intravenously
  • Drug TKI
    Administrated intravenously

Primary outcome measures

  • Adverse events [Time frame: Up to 2 years]
  • Recommended Phase 2 Dose [Time frame: 1 year]
Secondary outcome measures (9)
  • Peak concentration (Cmax) [Time frame: Up to 2 years]
  • Time to peak (Tmax) [Time frame: Up to 2 years]
  • Area under the concentration versus time curve (AUC) [Time frame: Up to 2 years]
  • Half-life time (t1/2) [Time frame: Up to 2 years]
  • Anti-Drug Antibody characteristics [Time frame: Up to 2 years]
  • Objective Response Rate [Time frame: 6 months]
  • Disease Control Rate [Time frame: 6 months]
  • Duration of Response [Time frame: Up to 2 years]
  • Progression-Free Survival [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 8 centers
  • Beijing You An Hospital, Capital Medical University — Beijing
  • The Ethics Committee of Cancer Hospital Chinese Academy of Medical Sciences. — Beijing
  • Peking Union Medical College Hospital — Beijing
  • Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou
  • Henan Cancer Hospital — Zhengzhou
  • The First Affiliated Hospital With Nanjing Medical University — Nanjing
  • Tianjin Cancer Hospital Airport Hospital — Tianjin
  • Lishui Central Hospital — Lishui

Identifiers

NCT: NCT07479485 · MRG006A-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗