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Clinical Trial Summary

The goal of this clinical trial is to about in Patients With Advanced Solid Tumors. The main question[s] it aims to answer are: - question 1:Evaluating the tolerability of BH002 injection in Chinese patients with advanced solid tumors - question 2:Obtain the pharmacokinetic (PK) characteristics of BH002 injection in Chinese patients with advanced solid tumors


Clinical Trial Description

Subjects will be administered BH002 intravenously. It is expected that there will be 2 to 4 dose groups, with 3 to 6 subjects enrolled in each group. The doses from low to high are 15 mg/m2,20 mg/m2,25 mg/m2,30 mg/m2,35 mg/m2. Subjects were injected with BH002 intravenously on the first day of each cycle, once during a 3-week period. The dose escalation for this trial will be 20mg/m2 as the starting dose. According to the traditional "3+3" dose escalation principle, 3 subjects are planned to be enrolled in each dose group at the same time. Safety, tolerability, and dose-limiting toxicities (DLTs) will be assessed within 21 days of first dose. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06231277
Study type Interventional
Source Zhuhai Beihai Biotech Co., Ltd
Contact
Status Completed
Phase Phase 1
Start date April 26, 2022
Completion date March 31, 2023

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