NCT05262413

A Study of QL1706 Plus Lenvatinib in Subjects With Advanced Renal Cell Carcinoma(RCC)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b, multicenter, open label, single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of QL1706 plus lenvatinib in subjects with advanced RCC.

Detailed description

This study included a screening period, a treatment period, and a post-treatment follow-up period. Safety will be monitored throughout the study. At the same time, the pharmacokinetics and immunogenicity of QL1706 and lenvatinib in subjects with advanced renal cell carcinoma were evaluated, and the preliminary efficacy of QL1706 combined with lenvatinib in subjects with advanced renal cell carcinoma was evaluated.

Conditions

• Advanced Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	QL1706 Plus Lenvatinib	QL1706 5mg/kg administered intravenously (IV), every 3 weeks, plus Lenvatinib 20 mg or 14mg administered orally, once daily.

Timeline

• Start date: 2022-02-28
• Primary completion: 2023-07-30
• Completion: 2024-07-30
• First posted: 2022-03-02
• Last updated: 2022-03-02