Trials / Terminated
TerminatedNCT04601610
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
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KN046 （PD-L1/CTLA4 BsAb） | KN046 5mg/kg Q3W |
| DRUG | Ningetinib Tosylate（multi-target TKI） | ningtinib QD, dose will be decided by investigator |
Timeline
- Start date
- 2021-06-07
- Primary completion
- 2022-05-30
- Completion
- 2022-05-30
- First posted
- 2020-10-26
- Last updated
- 2022-10-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04601610. Inclusion in this directory is not an endorsement.