NCT06232863

A Study of BH009 in Head and Neck Squamous Cell Carcinoma and Ovarian Cancer

A Phase I Study To Evaluate The Safety, Tolerability and Pharmacokinetics Of BH009 In Patients With Advanced Head And Neck Squamous (Non-nasopharyngeal) And Ovarian Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Zhuhai Beihai Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and tolerability and pharmacokinetics of BH009 in patients with advanced head and neck squamous (non-nasopharyngeal) and ovarian cancer.

Detailed description

This is a multicenter, open label phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic profile of BH009 in patients with advanced squamous head and neck cancer (non-nasopharyngeal) and ovarian cancer, and to initially explore its clinical effectiveness. This study will use a "3+3" dose escalation design to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of BH009.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	BH009	Every 28 days constitutes a treatment cycle, and administration on day 1, day 8, day 15 of each cycle

Timeline

• Start date: 2023-01-18
• Primary completion: 2024-03-30
• Completion: 2024-04-30
• First posted: 2024-01-31
• Last updated: 2024-02-02

Locations

5 sites across 1 country: China