NCT04699929

A Study to Evaluate YH001 in Subjects With Advanced Solid Tumors

A Open-Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability,Efficacy and Pharmacokinetics of YH001 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Eucure (Beijing) Biopharma Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose-escalation study of the study drug YH001 . The study is designed to determine the safety, tolerability and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of YH001 in subjects with advanced solid tumors.

Detailed description

This is a single arm clinical trial in subjects with advanced solid tumor receiving multiple doses of YH001 intravenously (IV). YH001 will be administered (IV) in 19-37 patients with advanced solid tumors. An accelerated titration method followed by a traditional 3+3 dose escalation scheme will be utilized to determine MTD(maximum tolerated dose) and/or RP2D(recommended phase 2 dose). Patients will be dosed at Dose A, Dose B, Dose C, Dose D, Dose E, Dose F and Dose G every 3 weeks (Q3W) for 15 weeks (5 cycles).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	YH001	YH001 will be administered intravenously over 60minutes every three weeks (Q3W) for up to 1 years .

Timeline

• Start date: 2021-01-26
• Primary completion: 2022-10-08
• Completion: 2022-10-08
• First posted: 2021-01-07
• Last updated: 2022-12-12

Locations

3 sites across 1 country: China