Spots Global Cancer Trial Database for Phase I Study of KN044 in Locally Advanced/Metastatic Solid Tumors

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Trial Identification

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

Official Title: Phase I Clinical Study of Safety，Tolerability， Pharmacokinetics and Pharmacodynamics of Recombinant Humanized Cytotoxic T Lymphocyte Antigen 4 Single Domain Antibody Fc Fusion Protein Injection in Subjects With Advanced Solid Tumors

Study ID: NCT04126590

Conditions

Advanced Solid Tumors

Interventions

KN044

Study Description

Brief 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.

Detailed 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.