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Phase I Study of KY-0118 in Subjects With Locally Advanced or Metastatic Solid Tumors

Neoplasms Clinical Trial

Official title:
A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KY-0118 in Subjects With Locally Advanced or Metastatic Solid Tumors

Clinical Trial Summary

This dose escalation and dose expansion study is to evaluate and characterize the tolerability, safety, pharmacokinetics and efficacy profile of single agent KY-0118 in Locally Advanced or Metastatic Solid Tumor Patients.

Clinical Trial Description

For Phase Ia It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, immunogenicity in subjects with locally advanced or metastatic solid tumor patients , and determine the appropriate dose of KY-0118. For Phase Ib it aims is to further evaluate the efficacy, safety, tolerability, pharmacokinetic properties, pharmacodynamic effects and immunogenicity of KY-0118 with appropriate dose groups (approximately 3-5 dose groups) in different Administration manner. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06175780
Study type Interventional
Source Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
Contact si li
Phone 17879528905
Email s.li@novatim-zj.com
Status Recruiting
Phase Phase 1
Start date December 28, 2022
Completion date December 28, 2025
View Details
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