NCT05451407

Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma

Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an open, single-center, multi-cohort phase Ib exploratory study, and 50 subjects are planned to be enrolled to observe the objective response rate of each subject. The safety evaluation of this study adopts common terminology criteria for adverse events version (CTCAE) 5.0 to evaluate the adverse events of drugs. Efficacy was evaluated using response evaluation criteria in solid tumors version (RECIST) 1.1 for immune-based therapeutics criteria.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	TQB2618 injection	Humanized IgG4 mab targeting TIM-3
DRUG	Toripalimab injection	Monoclonal antibody against Programmed death factor receptor 1

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2022-07-11
• Last updated: 2023-07-07

Locations

1 site across 1 country: China