Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04601610
Status:
TERMINATED
Last Update Posted:
2022-10-28
First Post:
2020-10-19
Brief Title:
KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma
Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co Ltd
Organization:
Jiangsu Alphamab Biopharmaceuticals Co Ltd
Study Overview
Official Title:
An Open Multi-center IbII Clinical Trial of KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsors development strategy adjustment resolution is terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgkg Q3W and the preset dose of ningatinib is 10 mg rapid titration 20 mg QD 30 mg QD and 40 mg QDDose 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None