A Study of AK112 in Patients With Unresectable Hepatocellular Carcinoma (HCC)

NCT ID: NCT05432492

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2024-08-31

Brief Summary

Phase II open label, multicenter study to evaluate the efficacy and safety of AK112 (PD-1/VEGF Bispecific) in patients with unresectable hepatocellular carcinoma (HCC).

Conditions

Hepatocellular Carcinoma

Study Design

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

Study Groups

Cohort 1

Subjects receive AK112 on Day 1 of every 3-week cycle (Q3W) until progression.

Group Type: EXPERIMENTAL

AK112

Intervention Type: DRUG

IV infusion, specified dose on specified days

Cohort 2

Subjects receive AK112 on Day 1 of every 3-week cycle (Q3W) until progression.

Group Type: EXPERIMENTAL

AK112

Intervention Type: DRUG

IV infusion, specified dose on specified days

Interventions

AK112

IV infusion, specified dose on specified days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
• 18 to 75 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Have a life expectancy of at least 3 months.
• BCLC stage B or C, not amenable to curative surgery.
• Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
• At least one measurable untreated lesion.
• Child-Pugh class A.
• Has adequate organ function.
• All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.

Exclusion Criteria

• With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
• History of malignancy other than HCC within 5 years, except that basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Have a history of hepatic encephalopathy or have a history of liver transplantation.
• With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
• Central nervous system (CNS) metastasis or meningeal metastasis.
• Prior immunotherapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
• Prior systemic bevacizumab and its analogues treatment.
• Severe bleeding tendency or coagulation dysfunction; occurred arteriovenous thromboembolic events or bleeding events due to esophageal and/or gastric varices within 6 months before the first administration.
• Known presence or history of required hormone treatment interstitial lung disease or non-infectious pneumonitis.
• Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Has undergone major surgery within 30 days prior to the first dose of study treatment.
• History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

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

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jingfeng Liu

Role: PRINCIPAL_INVESTIGATOR

Fujian Cancer Hospital

Central Contacts

Chengna Wang

Role: CONTACT

clinicaltrials@akesobio.com

+86(0760)89873999

Other Identifiers

AK112-207

Identifier Type: -

Identifier Source: org_study_id