NCT06011291

A Study of SYH2051 Monotherapy in Advanced Solid Tumors or in Combination With Radiotherapy in Locally Advanced Head and Neck Cancer

A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYH2051 Monotherapy in Patients With Advanced Solid Tumors or in Combination With Radiotherapy in Patients With Locally Advanced Head and Neck Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, dose-escalation phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of SYH2051 in patients with advanced solid tumors or in combination with radiotherapy (RT) in patients with locally advanced head and neck cancer.

Conditions

• Solid Tumors
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	SYH2051 tablets	Arm A: Five dose levels will be administered sequentially. Arm B and C: Concurrently administered with RT, and 2 weeks adjuvant treatment after RT.
RADIATION	Intensity-Modulated Radiation Therapy (IMRT)	Radical or adjuvant radiotherapy

Timeline

• Start date: 2023-08-15
• Primary completion: 2024-12-31
• Completion: 2025-08-31
• First posted: 2023-08-25
• Last updated: 2023-10-27

Locations

1 site across 1 country: China