NCT04640545

A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma

A Phase I Multi-center Study to Evaluate the Safety ,Tolerability and Efficacy of LBL-007 Combined With Toripalimab or LBL-007 Combined With Toripalimab and Axitinib Tablets in the Treatment of Unresectable or Metastatic Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Nanjing Leads Biolabs Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors

Detailed description

This trial is a multi-center, single-arm, open-label, dose-escalation and expansion phase I study of LBL-007 combined with Toripalimab and Axitinib in the treatment of unresectable or metastatic melanoma. It is divided into Study Part A and Study Part B. The safety, tolerability, kinetic characteristics, immunogenicity and preliminary efficacy of the subjects were evaluated. Both study part A and study part B are studied in two phases: dose escalation and dose expansion

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	LBL-007	LBL-007 will be administered intravenously every two weeks (Q2W) .
DRUG	Toripalimab	Toripalimab Injection will be administered by intravenously (Q2W) .
DRUG	Axitinib Tablets	Axitinib Tablets On-demand administration

Timeline

• Start date: 2020-05-12
• Primary completion: 2024-08-19
• Completion: 2024-08-19
• First posted: 2020-11-23
• Last updated: 2025-09-18

Locations

8 sites across 1 country: China