Study to Evaluate Safety and Effectiveness of LBL-024 Alone or With LBL-007 or Toripalimab in Adults with Advanced Melanoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of LBL-024 alone and in combination with LBL-007 or toripalimab in patients with advanced melanoma. This open-label, multicenter study includes Phase Ib and Phase II sections to explore different dosing regimens and treatment combinations in various melanoma subtypes. The study aims to better understand how these treatments work for this serious skin cancer. The study has three treatment groups in Phase Ib one receiving LBL-024 alone, another receiving LBL-024 combined with LBL-007, and a third receiving LBL-024 combined with toripalimab. Phase II includes a randomized part for cutaneous, acral, and unknown primary melanoma and a single-arm extension for mucosal melanoma, selecting the best combination from Phase Ib results. Treatments are given by intravenous infusion. Participants will provide samples for testing and undergo regular assessments including monitoring for side effects and evaluating tumor response. Researchers will measure outcomes such as adverse events, response rates, and progression-free survival during and after treatment, with follow-up extending up to 90 days after drug withdrawal. The study plans to enroll up to 200 subjects until late 2027.

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