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KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma

An Open, Multi-center, Ib/II Clinical Trial of KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma

NCT04601610•Jiangsu Alphamab Biopharmaceuticals Co., Ltd

View on ClinicalTrials.gov

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.

Detailed Description

The study consists of dose escalation and dose expansion, the mTPI-2 (Modified Toxicity Probability Interval) will be used for dose exploration. The preset dose of KN046 is 5 mg/kg Q3W and the preset dose of ningatinib is 10 mg (rapid titration), 20 mg QD, 30 mg QD, and 40 mg QD.Dose expansion will be divided into two cohorts, cohort 1 will enroll subjects who have not received system therapy and cohort 2 will enroll subjects who have previously received at least first-line system therapy.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (1)

Chinese Pla General Hospital Chinese Pla Medical School

Beijing, Beijing Municipality, China

Key Dates

Start Date

June 7, 2021

Primary Completion Date

May 30, 2022

Completion Date

May 30, 2022

Last Updated

October 28, 2022

Enrollment

ACTUAL participants

Conditions

Advanced HCC

Interventions

KN046 （PD-L1/CTLA4 BsAb）

DRUG

Ningetinib Tosylate（multi-target TKI）

DRUG

KD6001 in Combination With Anti-PD-1 Antibody±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors

NCT05906524

Advanced HCCOther Solid Tumors

View study

COMPLETEDPHASE3

Elimination of CD4+CD25+ Regulatory T Cells in Patients With Hepatocellular Carcinoma

NCT00396682

Advanced HCC

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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