NCT06175780

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 189 (estimated)
• Sponsor: Novatim Immune Therapeutics (Zhejiang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms
• Neoplasms by Histologic Type

Interventions

Type	Name	Description
DRUG	KY-0118	KY-0118 is to be injected intravenously with a dose of 0.3μg/kg, 1μg/kg, 3μg/kg, 6μg/kg, 12μg/kg, 24μg/kg, 36μg/kg, 48μg/kg or 64μg/kg until disease progresses or unacceptable tolerability occurs;
DRUG	KY-0118	KY-0118 is to be injected intravenously with a dose of dose1\~dose5 weekly until disease progresses or unacceptable tolerability occurs;
DRUG	KY-0118	KY-0118 is to be injected subcutaneously with a dose of dose1\~dose5 weekly until disease progresses or unacceptable tolerability occurs;

Timeline

• Start date: 2022-12-28
• Primary completion: 2025-12-28
• Completion: 2025-12-28
• First posted: 2023-12-19
• Last updated: 2023-12-26

Locations

8 sites across 1 country: China