KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma

• Status: Not yet recruiting
• Trial end date: 2023-06-15
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open, multi-center clinical trial, the purpose is to study the safety and preliminary efficacy of KN046 combined with Ningatinib in subjects with advanced hepatocellular carcinoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Collaborator: Sunshine Lake Pharma Co., Ltd.

Criteria

Inclusion Criteria:

• Has a diagnosis of hepatocellular carcinoma confirmed by histology or cytology；

• Barcelona Clinic Liver Cancer (BCLC) Stage B or C；

• ECOG performance status: 0-1；

• Child Pugh score≤7；

• 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;

• Past or present hepatic encephalopathy; or Budd-Chiari syndrome; or 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.); or have a history of ≥ grade 3 immune-related adverse reactions; or hyperprogressive after immunotherapy previously；

• 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 liver transplantation;

• History of interstitial lung disease or non-infectious pneumonia;

• History of allergic reactions to related drugs;

• LVEF< 50% or LLN

• 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;