The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma

NCT ID: NCT04542837

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-11
• Study Completion Date: 2024-03-15

Brief Summary

This ia a single-arm, not-randomized, open-label phase II study. The purpose of this study is to evaluate the safety and efficacy of KN046 (PD-L1 /CTLA-4 Bispecific antibody) combined with Lenvatinib(TKI) for the treatment of advanced hepatocellular carcinoma.

Conditions

HCC

Study Design

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

Study Groups

KN046 plus Lenvatinib

Group Type: EXPERIMENTAL

KN046

Intervention Type: BIOLOGICAL

Subjects enrolled in the study will be intravenously administered KN046 5mg/kg every 3 weeks (Q3W), until disease progression, or unacceptable toxicity, or withdrawal of consent, or lost to follow-up, or died, or treatment for 2 years, or the investigator decides to terminate.

Lenvatinib

Intervention Type: DRUG

Subjects enrolled in the study will receive lenvatinib 12 mg (BW≥60 kg) or 8 mg (BW\<60 kg) orally once a day (QD) ,until disease progression, or unacceptable toxicity, or withdrawal of consent, or lost to follow-up, or died, or treatment for 2 years, or the investigator decides to terminate.

Interventions

KN046

Subjects enrolled in the study will be intravenously administered KN046 5mg/kg every 3 weeks (Q3W), until disease progression, or unacceptable toxicity, or withdrawal of consent, or lost to follow-up, or died, or treatment for 2 years, or the investigator decides to terminate.

Intervention Type: BIOLOGICAL

Lenvatinib

Subjects enrolled in the study will receive lenvatinib 12 mg (BW≥60 kg) or 8 mg (BW\<60 kg) orally once a day (QD) ,until disease progression, or unacceptable toxicity, or withdrawal of consent, or lost to follow-up, or died, or treatment for 2 years, or the investigator decides to terminate.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Has a diagnosis of hepatocellular carcinoma confirmed by histology or cytology；
• Barcelona Clinic Liver Cancer (BCLC) Stage B or C；
• Age ≥18 years or ≤75 years for both genders；
• ECOG performance status: 0-1；
• Child Pugh score≤7；
• LVEF≥50% or above LLN of the research institution；
• Enough organ function；
• Has at least one measurable lesion based on RECIST 1.1；
• Life expectancy ≥3 months；
• Patients must be able to understand and willing to sign a written informed consent document；

Exclusion Criteria

• Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma etc;
• Tumor thrombus invasion at the main portal vein (Vp4), inferior vena cava or heart involvement;
• Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.);
• Subjects who have received liver local treatment (transcatheter chemoembolization, transcatheter embolization, hepatic artery perfusion, radiotherapy, radioembolization or ablation) within 4 weeks before administration;
• Subjects who need corticosteroids or immunosuppressive agents for systemic therapy;
• Any previous or current active autoimmune disease or history of autoimmune disease;
• History of hepatic encephalopathy or liver transplantation;
• History of interstitial lung disease or non-infectious pneumonia;
• History of allergic reactions to related drugs;
• Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy;
• With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable;
• Subjects with clinically significant gastrointestinal bleeding or thrombosis or embolic events within 6 months;
• Untreated hepatitis infection: HBV DNA>2000IU/ml or10000 copies/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive;
• Evidence of active pulmonary tuberculosis (TB);
• Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
• Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage;

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

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Baocai Xing

Director of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Countries

China

Other Identifiers

20200825

Identifier Type: -

Identifier Source: org_study_id