NCT07099430

A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma

An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 Monotherapy, LBL-024 in Combination With LBL-007 or Toripalimab in Patients With Advanced Melanoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Nanjing Leads Biolabs Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multicenter phase Ib/II study to evaluate the efficacy and safety of LBL-024 monotherapy, LBL-024 in combination with LBL-007 or toripalimab in patients with advanced melanoma,To evaluate the preliminary efficacy and safety of LBL-024 monotherapy and combination therapy in patients with advanced melanoma.

Detailed description

This trial includes two phases, Phase Ib and Phase II. Phase Ib is an exploratory stage of safety and efficacy in a single-arm, open-label study, including three cohorts (different dosing regimens).Phase Ib includes three cohorts, Cohort 1 (LBL-024 monotherapy), Cohort 2 (LBL-024 + LBL-007 combination) and Cohort 3 (LBL-024 + toripalimab combination). Phase II includes Part A and Part B.Part A is a randomized, open-label, positive-controlled extension study. It plans to enroll patients with melanoma of the cutaneous, Acral, and unknown primary. Eligible subjects will be randomly assigned in a 2:1 ratio \[Stratification factor: Acral subtype (Yes vs. No)\] to either the Experimental Group or the Control Group. Part B is a single-arm extension study enrolling only patients with mucosal melanoma,and will select a drug combination based on phase Ib efficacy for expansion study. This study requires subjects to provide relevant samples for testing. The trial will enroll up to 200 subjects.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	LBL-024 for Injection	LBL-024 , Intravenous infusion.
DRUG	LBL-007 Injection	LBL-007 , intravenous infusion.
DRUG	Toripalimab Injection	Toripalimab , intravenous infusion.

Timeline

• Start date: 2025-09-05
• Primary completion: 2027-10-30
• Completion: 2027-12-30
• First posted: 2025-08-01
• Last updated: 2025-12-04

Locations

15 sites across 1 country: China