NCT06231277

Phase I Clinical Trial of BH002 in Patients With Advanced Solid Tumors

Phase I Clinical Trial of Safety, Tolerability and Pharmacokinetics of BH002 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Zhuhai Beihai Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Solid Tumours

Interventions

Type	Name	Description
DRUG	BH002	Every 21 days constitutes a treatment cycle, and administration begins on the first day of each cycle

Timeline

• Start date: 2022-04-26
• Primary completion: 2023-03-10
• Completion: 2023-03-31
• First posted: 2024-01-30
• Last updated: 2024-01-30

Locations

2 sites across 1 country: China