Spots Global Cancer Trial Database for Phase I Study of KY-0118 in Subjects With Locally Advanced or Metastatic Solid Tumors

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Trial Identification

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

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

Study ID: NCT06175780

Conditions

Neoplasms

Neoplasms by Histologic Type

Interventions

KY-0118

Study Description

Brief 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.

Detailed 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.