Phase I Study of KN044 in Locally Advanced/Metastatic Solid Tumors
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- STATUS
- Recruiting
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- days left to enroll
- 34
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- participants needed
- 39
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- sponsor
- Changchun Intellicrown Pharmaceutical Co. LTD
Summary
This is an open-label, multicenter, dose-escalation phase I study to assess the safety, tolerability and preliminary efficacy of KN044 in participants with all advanced solid tumors who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) , to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of KN044 as a single agent in adult participants with advanced solid tumors.
Description
This study will involve patients and follow the standard "3 + 3"design. KN044 will be antimedical intravenously over 30 minutes with planned doses of 0.03, 0.1, 0.3, 1, 3, 6,10 mg/kg Once every 3 weeks for first 4 doses, then every 3, or 6, or 12 weeks for up to 1 year if no intolerable toxicities occur and per agreement with investigator antimedical monitor based on emerging data.
Details
| Condition | Advanced Solid Tumors |
|---|---|
| Treatment | KN044 |
| Clinical Study Identifier | NCT04126590 |
| Sponsor | Changchun Intellicrown Pharmaceutical Co. LTD |
| Last Modified on | 24 February 2022 |
Eligibility
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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