NCT07479485 MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II)
| NCT ID | NCT07479485 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Lepu Biopharma Co., Ltd. |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 160 participants in total. It began in 2026-04-08 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: 1. Able to understand and provide written informed consent, and comply with the requirements specified in the protocol. 2. Life expectancy ≥ 3 months. 3. Must provide tumor tissue specimens for GPC3 testing. 4. 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. 5. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and modified RECIST (mRECIST). 6. No prior systemic antineoplastic therapy for unresectable HCC before first dose administration. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to first study drug administration. 8. Adequate organ function as specified. 9. 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. 10. 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: 1. Prior histologically/cytologically confirmed diagnosis of hepatocellular carcinoma with fibrolamellar, sarcomatoid, cholangiocarcinoma, or other components. 2. History of hepatic failure or hepatic encephalopathy, or history of liver transplantation. 3. Pleural effusion, ascites, or pelvic effusion, or clinically significant pericardial effusion. 4. Acute or chronic active hepatitis B or hepatitis C infection. 5. Central nervous system metastases. 6. Prior locoregional therapy for hepatocellular carcinoma within 4 weeks before first dose administration. 7. Receipt of live attenuated vaccines within 4 weeks before first dose or planned administration during the study period. 8. Major surgical procedure within 4 weeks before first dose, or the presence of unhealed wounds, ulcers, or bone fractures. 9. Uncontrolled or poorly controlled medical conditions. 10. Toxicities from prior therapy that have not resolved to Grade 0 or 1 before first dose of study treatment. 11. 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. 12. Patients with double or multiple primary malignancies. 13. Hypersensitivity to any component or excipient of the investigational product. 14. Active or poorly controlled severe infection. 15. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07479485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07479485 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07479485 currently recruiting?
Yes, NCT07479485 is actively recruiting participants. Contact the research team at ra_bj@lepubiopharma.com for enrollment information.
Where is the NCT07479485 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Fuzhou, China and 4 additional locations.
Who is sponsoring the NCT07479485 clinical trial?
NCT07479485 is sponsored by Lepu Biopharma Co., Ltd.. The trial plans to enroll 160 participants.
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