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

NCT04728321 | Completed Phase 2

• 1 other identifier: AK104-209
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

Anti-PD-1; Anti-CTLA-4; Bispecific

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.

  Up to 2 years

Secondary Outcomes (4)

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Number of participants with adverse events (AEs)

  the time of informed consent signed through 90 days after the last dose of AK104 and Lenvatinib

Study Arms (2)

AK104

EXPERIMENTAL

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

Biological: AK104

AK104 and Lenvatinib

EXPERIMENTAL

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

Biological: AK104 lenvatinib

Interventions

AK104 lenvatinib BIOLOGICAL

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

AK104 and Lenvatinib

AK104 BIOLOGICAL

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

AK104

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead
• Akeso Pharmaceuticals, Inc.: collaborator

Study Sites (1)

The first affilited hospital zhejiang university school of medcine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Tingbo Liang, MD

  The First Affiliated Hospital Zhejiang University School of Medcine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 28, 2021
• Study Start: January 27, 2021
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

CN (1)