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

NCT05432492 | Completed Phase 2

• 1 other identifier: AK112-207
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Number of patients with Adverse Events (AEs)

  Up to approximately 2 years

• Objective Response Rate (ORR) Per RECIST v1.1

  Up to approximately 2 years

• Objective Response Rate (ORR) Per mRECIST

  Up to approximately 2 years

Secondary Outcomes (5)

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of Response (DoR)

  Up to approximately 2 years

• Time to response (TTR)

  Up to approximately 2 years

• Progression free survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

Other Outcomes (3)

• Percentage of participants who obtain R0 resection

  Up to approximately 2 years

• Percentage of participants who obtain a major pathologic responses (MPR)

  Up to approximately 2 years

• Percentage of participants who obtain a pathologic complete response (pCR)

  Up to approximately 2 years

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Drug: AK112

Cohort 2

EXPERIMENTAL

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

Drug: AK112

Interventions

AK112 DRUG

IV infusion, specified dose on specified days

Cohort 1; Cohort 2

Eligibility Criteria

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

You may qualify if:

• Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 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

• Jingfeng Liu

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: August 3, 2022
• Primary Completion: April 30, 2025
• Study Completion: June 14, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

CN (1)