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

Phase 2

Completed

• Conditions: HCC
• Interventions: Biological: KN046; Drug: Lenvatinib

• Registration Number: NCT04542837
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-09
• Study Start: 2020-09-11
• Primary Completion: 2022-02-23
• Status Verified: 2024-03
• Study Completion: 2024-03-15
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KN046 plus Lenvatinib	KN046	-
KN046 plus Lenvatinib	Lenvatinib	-

Primary Outcome Measures

Name	Time	Method
ORR	1 year after the last patient's enrollment	objective response rate (ORR) based on the RECIST 1.1 by investigator

Secondary Outcome Measures

Name	Time	Method
OS	2 year after the last patient's enrollment	overall survival
DOR	1 year after the last patient's enrollment	duration of response (DOR) based on the RECIST 1.1，mRECIST 1.1 and imRECIST respectively by investigator
ORR	1 year after the last patient's enrollment	objective response rate (ORR) based on the mRECIST 1.1 and imRECIST respectively by investigator
DCR	1 year after the last patient's enrollment	disease control rate (DCR) based on the RECIST 1.1，mRECIST 1.1 and imRECIST respectively by investigator
TTR	1 year after the last patient's enrollment	time to response (TTR) based on the RECIST 1.1，mRECIST 1.1 and imRECIST respectively by investigator
PFS	1 year after the last patient's enrollment
OS-12m rate	1 year after the last patient's enrollment	12-month overall survival rate

Trial Locations

Locations (2)

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China