A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma

NCT ID: NCT04444167

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2023-11-20

Brief Summary

An open-label multi-center phase Ib/II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.

Detailed Description

This is a multi-center, multi-cohort, open-label phase 1b/2 clinical study to evaluate the anti-tumor activity, safety, PK profile, immunogenicity and potential biomarkers of AK104 plus lenvatinib for the treatment of advanced hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK104 and Lenvatinib

AK104 6 mg/kg IV every 2 weeks (Q2W) Lenvatinib 12mg weight≥60kg or 8mg weight\<60kg,PO QD

Group Type: EXPERIMENTAL

AK104

Intervention Type: BIOLOGICAL

Subjects will receive AK104 and lenvatinib until disease progression or for a maximum of 24 months

Lenvatinib

Intervention Type: DRUG

Subjects will receive AK104 and lenvatinib until disease progression for a maximum of 24 months

Interventions

AK104

Subjects will receive AK104 and lenvatinib until disease progression or for a maximum of 24 months

Intervention Type: BIOLOGICAL

Lenvatinib

Subjects will receive AK104 and lenvatinib until disease progression for a maximum of 24 months

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso Pharmaceuticals, Inc.

OTHER

Sponsor Role: collaborator

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Bai, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Shunchang Jiao, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Qiao Q, Han C, Ye S, Li J, Shao G, Bai Y, Xu A, Sun M, Wang W, Wu J, Huang M, Song L, Huang L, Liu T, Liu W, Wang ZM, Li B, Xia M, Bai L. The efficacy and safety of cadonilimab combined with lenvatinib for first-line treatment of advanced hepatocellular carcinoma (COMPASSION-08): a phase Ib/II single-arm clinical trial. Front Immunol. 2023 Oct 24;14:1238667. doi: 10.3389/fimmu.2023.1238667. eCollection 2023.

Reference Type: DERIVED

PMID: 37942328 (View on PubMed)

Other Identifiers

AK104-206

Identifier Type: -

Identifier Source: org_study_id