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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase II Study of AK112 (PD-1/VEGF Bispecific) in Patients With Unresectable Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05432492
• Other study ID #: AK112-207
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 2022
• Est. completion date: August 2024

Study information

• Verified date: June 2022
• Source: Akeso
• Contact: Chengna Wang
• Phone: +86(0760)89873999
• Email: clinicaltrials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• AK112
IV infusion, specified dose on specified days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of participants who obtain R0 resection		Up to approximately 2 years
Other	Percentage of participants who obtain a major pathologic responses (MPR)		Up to approximately 2 years
Other	Percentage of participants who obtain a pathologic complete response (pCR)		Up to approximately 2 years
Primary	Number of patients with Adverse Events (AEs)		Up to approximately 2 years
Primary	Objective Response Rate (ORR) Per RECIST v1.1		Up to approximately 2 years
Primary	Objective Response Rate (ORR) Per mRECIST		Up to approximately 2 years
Secondary	Disease control rate (DCR)		Up to approximately 2 years
Secondary	Duration of Response (DoR)		Up to approximately 2 years
Secondary	Time to response (TTR)		Up to approximately 2 years
Secondary	Progression free survival (PFS)		Up to approximately 2 years
Secondary	Overall survival (OS)		Up to approximately 2 years