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Completed

NCT Number: NCT04728321

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The first affilited hospital zhejiang university school of medcine

Hangzhou, Zhejiang, 310000, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AK104 lenvatinib

Biological

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

AK104

Biological

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

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: Up to 2 years

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

Secondary outcomes

  1. Disease control rate (DCR)

    Time frame: Up to 2 years

    The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.

  2. Duration of response (DoR)

    Time frame: Up to 2 years

    Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first

  3. Progression-free survival (PFS)

    Time frame: Up to 2 years

    Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first

  4. Number of participants with adverse events (AEs)

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

    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Collaborators

  • Akeso Pharmaceuticals, Inc.

Registry information

Official study title

An Open-Label Multi-Center Phase II Study of Anti-PD-1/CTLA-4 Bispecific Antibody AK104 Alone or in Combination With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 28, 2021
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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