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

NCT07479485 | Not Yet Recruiting Phase 1

• 1 other identifier: MRG006A-002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

Hepatocellular Carcinoma

Keywords

MRG006A; Pucotenlimab; Bevacizumab; TKI

Outcome Measures

Primary Outcomes (2)

• Adverse events

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

  Up to 2 years

• Recommended Phase 2 Dose

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

  1 year

Secondary Outcomes (9)

• Peak concentration (Cmax)

  Up to 2 years

• Time to peak (Tmax)

  Up to 2 years

• Area under the concentration versus time curve (AUC)

  Up to 2 years

• Half-life time (t1/2)

  Up to 2 years

• Anti-Drug Antibody characteristics

  Up to 2 years

Study Arms (3)

MRG006A+Pucotenlimab + Bevacizumab

EXPERIMENTAL

Drug: MRG006A

MRG006A+ PD1/VEGF antibody

EXPERIMENTAL

Drug: MRG006A

MRG006A+ TKI

EXPERIMENTAL

Drug: MRG006A

Interventions

MRG006A DRUG

Administrated intravenously

Also known as: Pucotenlimab, Bevacizumab

MRG006A+Pucotenlimab + Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lepu Biopharma Co., Ltd.: lead

Study Sites (8)

Beijing You An Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

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

Beijing, Beijing Municipality, 100021, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 350001, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

The First Affiliated Hospital With Nanjing Medical University

Nanjing, Jiangsu, 210006, China

Location

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, 300308, China

Location

Lishui Central Hospital

Lishui, Zhejiang, 323000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Program Director

CONTACT

86-21- 67680899; ra_bj@lepubiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)