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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Melanoma

In brief

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.

Key facts

Study ID

NCT07099430

Run by

Nanjing Leads Biolabs Co.,Ltd

People needed

200

Starts

2025-09-05

Expected to finish

2027-12-30

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Agree to follow the trial treatment regimen, visit schedule,laboratory test, and comply with other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
• At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.
• The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
• The expected survival time is at least 12 weeks.
• According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours）, the subjects enrolled have at least one measurable neoplasm lesion.
• Male of childbearing potential and Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug.

You may not qualify if…

• Subjects who received live vaccination within 4 weeks before the first dose or were planned to receive live vaccination during the study period and 4 weeks after the dose.
• Major surgery or other treatment or diagnosis that has a significant impact on the subject within 4 weeks before the first dose.
• Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.
• History of severe cardiovascular and cerebrovascular disorder.
• Active infectious disease.
• History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
• Women during pregnancy or lactation.
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Where it is running

• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (enrolling)
• Shandong Cancer Hospital — Jinan, Shandong, China (enrolling)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (enrolling)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (enrolling)
• Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
• Tianjin Medical University Cancer Institute &Hospital — Tianjin, Tianjin Municipality, China
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China
• The First Hospital of Jilin University — Changchun, Jilin, China
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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