A Phase 1b Study of GKL-006 Injection in Patients With Unresectable Hepatocellular Carcinoma

This Phase 1b study evaluates multiple doses of GKL-006 Injection in participants with unresectable hepatocellular carcinoma (HCC).

The purpose of this study is to evaluate the safety and tolerability of multiple doses of GKL-006 Injection. The study will also evaluate pharmacokinetic and pharmacodynamic characteristics of GKL-006 Injection, how it affects the body, and whether it shows preliminary anti-tumor activity in patients with HCC according to mRECIST.

Participants will receive GKL-006 Injection and TACE treatment. They will be followed for adverse events, tumor response, disease progression, subsequent anti-tumor therapy, and survival.

Inclusion criteria

• Voluntarily participates in the study and provides written informed consent.
• Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma.
• Has CNLC stage II to IIIa disease.
• Has not received transarterial chemoembolization within 6 months before screening.
• Has at least one measurable lesion according to mRECIST.
• Child-Pugh class A or B.
• ECOG performance status of 0 - 2.
• Has not received radiotherapy, chemotherapy, targeted therapy, or immunosuppressive therapy within 4 weeks before screening.

Exclusion criteria

• Has a known allergy to the investigational product or related components, including human serum albumin.
• Has another incurable malignancy within 5 years before screening or concurrently, except for cured basal cell carcinoma of the skin, carcinoma in situ, or breast cancer without recurrence for more than 3 years after radical surgery.
• Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma.
• Has major vascular invasion on imaging.
• Has hepatic encephalopathy within 4 weeks before screening.
• Has clinically symptomatic ascites or pleural effusion requiring drainage, or has undergone thoracic or abdominal fluid drainage within 2 weeks before enrollment.