RecruitingPhase 1Phase 2NCT07099430

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


Sponsor

Nanjing Leads Biolabs Co.,Ltd

Enrollment

200 participants

Start Date

Sep 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing three treatment options — LBL-024 alone, LBL-024 combined with LBL-007, or LBL-024 combined with toripalimab (an immune checkpoint drug) — for people with advanced melanoma (a serious form of skin cancer). Researchers want to see which approach is safest and most effective. **You may be eligible if...** - You are 18 or older - You have advanced melanoma with measurable tumor(s) - Your daily functioning is good (ECOG 0–1) - You are expected to survive at least 12 weeks - You are willing to use effective contraception during treatment and for 6 months after **You may NOT be eligible if...** - You have received a live vaccine within 4 weeks of starting the study - You have had major surgery or another major procedure recently - You have active or recurring autoimmune disease - You have serious heart or brain vascular disease - You have an active infection - You are pregnant or breastfeeding - You have a history of mental illness, alcohol abuse, or drug addiction affecting judgment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLBL-024 for Injection

LBL-024 , Intravenous infusion.

DRUGLBL-007 Injection

LBL-007 , intravenous infusion.

DRUGToripalimab Injection

Toripalimab , intravenous infusion.


Locations(15)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shandong Cancer Hospital

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute &Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07099430


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