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KN044 0.03 mg/kg dose group,once every 3 weeks，a total of four cycles

KN044 0.1 mg/kg dose group,once every 3 weeks，a total of four cycles

KN044 0.3mg/kg dose group,once every 3 weeks，a total of four cycles

KN044 1 mg/kg dose group,once every 3 weeks，a total of four cycles

KN044 3 mg/kg dose group,once every 3 weeks，a total of four cycles

KN044 6mg/kg dose group,once every 3 weeks，a total of four cycles

KN044 10mg/kg dose group,once every 3 weeks，a total of four cycles

The modified phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of KN044: 0.03mg/kg,0.3 mg/kg,1 mg/kg,3 mg/kg,6 mg/kg,10 mg/kg.

KN044

Shiqi Bai

Rui Chen

chunmei Bai

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.

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.

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

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

Dose-limiting toxicity observation period 6 weeks after the first dose

the adverse events are recorded according to the actual occurrence

The data of the clinical research center is collected and analyzed according to the time point of the test flow chart

According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.

According to the test schedule, the blood volume of each subject's anti-drug antibodies was analyzed and anti-drug antibodies analysis was performed.

Evaluation of tumor response according to RESISTv1.1 criteria, complete relief（CR), Partial relief(PR), Stable disease(SD), PD、ORR\[CR＋PR\]）、Disease control rate(DCR\[CR＋PR＋SD\]）、PFS、DOR

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I Study of KN044 in Locally Advanced/Metastatic Solid Tumors	NCT04126590	Advanced Solid ...	KN044	18 Years - 75 Years	Changchun Intellicrown Pharmaceutical Co. LTD
Phase I Study of KN044 in Locally Advanced/Metastatic Solid Tumors	NCT04126590	Advanced Solid ...	KN044	18 Years - 75 Years	Changchun Intellicrown Pharmaceutical Co. LTD

Spots Global Cancer Trial Database for kn044

Every month we try and update this database with for kn044 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for kn044

Every month we try and update this database with for kn044 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for kn044 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.