A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Alone or in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma

Akeso

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Biological: AK104 lenvatinib; Biological: AK104

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04728321

AK104-209

Details and patient eligibility

About

An open-label multi-center phase II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 alone or in combination with lenvatinib in patients with advanced hepatocellular carcinoma.

Full description

This is a multi-center, multi-cohort, open-label phase 2 clinical study to evaluate the anti-tumor activity, safety, PK profile, immunogenicity and potential biomarkers of AK104 alone or in combination with for the treatment of advanced hepatocellular carcinoma

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent form voluntarily.
• Histologically or cytologically documented hepatocellular carcinoma.
• BCLC stage C, and non-resectable BCLC stage B .
• At least one measurable lesion according to RECIST criteria.
• ECOG of 0 or 1.
• Adequate organ function.
• Estimated life expectancy of ≥3 months.
• For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent

Exclusion criteria

• Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
• History of hepatic encephalopathy or liver transplantation.
• Clinical significance of hydrothorax, ascites or pericardial effusion.
• Central nervous system metastases and/or carcinomatous meningitis.
• Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
• Occurred arteriovenous thromboembolic events within 6 months before the first administration.
• Tumor volume > 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus.
• Inadequately controlled arterial hypertension.
• Attack of symptomatic congestive heart failure (LVEF<50%); History of congenital long QT syndrome.
• Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.
• Severe infections.
• Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
• Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.
• Unable to receive an enhanced CT or MRI scan of the liver.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

AK104

Experimental group

Description:

AK104 15mg/kg IV every 3weeks (Q3W)

Treatment:

Biological: AK104

AK104 and Lenvatinib

Experimental group

Description:

AK104 15 mg/kg IV every 3 weeks (Q3W) Lenvatinib 12mg weight≥60kg or 8mg weight\<60kg,PO QD

Treatment:

Biological: AK104 lenvatinib