NCT05309512

Clinical Study of KN052 in Chinese Subjects With Advanced Solid Tumors

A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of KN052 in Chinese Subjects With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ia/Ib open, multicenter study of solid tumor subjects in China.Including dose increasing period and cohort expansion period.A BOIN design is used in the dose escalation phase,a total of 8 dose groups were designed.In the expansion phase of the cohort, 15 to 30 subjects will be enrolled in a specific tumor type (liver cancer, stomach cancer, kidney cancer, melanoma, urothelial carcinoma, and other tumors determined by the SMC).

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	KN052	0.01mg/kg, 0.1mg/kg, 0.3mg/kg, 1mg/kg, 2mg/kg, 4mg/kg, 6mg/kg, 9mg/kg, RP2D once every two or three weeks intravenously

Timeline

• Start date: 2022-05-27
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2022-04-04
• Last updated: 2024-05-01

Locations

1 site across 1 country: China