NCT05823246

Safety and Efficacy Study of QLF31907 in Advanced Melanoma and Urothelial Carcinoma

A Phase II Study to Evaluate the Efficacy and Safety of QLF31907 Injection in Patients With Advanced Melanoma and Urothelial Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety, tolerability and efficacy of every-2-week dosing of QLF31907 injection in patients with advanced melanoma and urothelial carcinoma.

Detailed description

This study is divided into two parts. The first part is the safety and tolerability observation period, mainly observing the safety and tolerability of QLF31907. The second part is mainly the efficacy observation period, further evaluating the efficacy and safety of QLF31907 in patients with advanced melanoma and urothelial carcinoma.

Conditions

• Melanoma
• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	QLF31907	Intravenous infusion once every two weeks. The dose administered in part 2 will depend on the outcome of part 1.

Timeline

• Start date: 2023-04-24
• Primary completion: 2023-10-01
• Completion: 2024-07-01
• First posted: 2023-04-21
• Last updated: 2023-05-26

Locations

6 sites across 1 country: China