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

Peking University Cancer Hospital & Institute2 sites in 1 country55 target enrollmentSeptember 11, 2020

ConditionsHCC

InterventionsKN046 Lenvatinib

DrugsKN046 Lenvatinib

Overview

Phase: Phase 2
Intervention: KN046
Conditions: HCC
Sponsor: Peking University Cancer Hospital & Institute
Enrollment: 55
Locations: 2
Primary Endpoint: ORR
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 11, 2020

End Date

March 15, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking University Cancer Hospital & Institute

Responsible Party

Principal Investigator

Baocai Xing

Director of Surgery

Peking University Cancer Hospital & Institute

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;