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

HCC Clinical Trial

Official title:

A Phase II Study Evaluating the Safety and Efficacy of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542837
• Other study ID #: 20200825
• Status: Completed
• Phase: Phase 2
• Start date: September 11, 2020
• Est. completion date: March 15, 2024

Study information

• Verified date: March 2024
• Source: Peking University Cancer Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 15, 2024
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HCC

Intervention

Biological:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

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