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Phase I Study of KN044 in Locally Advanced/Metastatic Solid Tumors

2019-10-21 12:45:40 | BioPortfolio

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.

Study Design

Conditions

Advanced Solid Tumors

Intervention

KN044

Status

Not yet recruiting

Source

Changchun Intellicrown Pharmaceutical Co. LTD

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-21T12:45:40-0400

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