LBL-024 alone or combined with LBL-007 or toripalimab for 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

This research will test whether LBL-024, given alone or with LBL-007 or with the PD-1 drug toripalimab, helps people with advanced melanoma.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (Industry-sponsored)
• Drugs / interventions: toripalimab
• Locations: 15 sites (Fuzhou, Fujian and 14 other locations)
• Trial ID: NCT07099430 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter Phase Ib/II program enrolling up to 200 adults with advanced melanoma to study LBL-024 as monotherapy and in two combination regimens. Phase Ib is a single-arm, exploratory safety and activity assessment with three cohorts (LBL-024 alone, LBL-024 + LBL-007, LBL-024 + toripalimab). Phase II includes a randomized, open-label Part A (2:1 randomization versus a positive control, stratified by acral subtype) and a single-arm Part B expansion for mucosal melanoma, with the Part B regimen chosen based on Phase Ib results. The trial requires scheduled clinic visits and collection of biological samples for testing and safety monitoring across multiple Chinese cancer centers.

Who should consider this trial

Good fit: Adults (≥18 years) with advanced melanoma (including cutaneous, acral, mucosal, or unknown primary as applicable), ECOG 0–1, at least one measurable lesion by RECIST 1.1, expected survival ≥12 weeks, willing to consent and follow contraception and sampling requirements.

Not a fit: Patients with poor performance status (ECOG >1), no measurable disease, pregnancy, recent live vaccination or other exclusionary medical conditions, or those unwilling to comply with visits or sample collection are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the regimens could provide an additional treatment option that improves disease control for some patients with advanced melanoma.

How similar studies have performed: Combining novel agents with PD-1 inhibitors like toripalimab has shown activity in melanoma in other trials, but LBL-024 and LBL-007 are investigational and have limited prior human data.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
4. The expected survival time is at least 12 weeks.
5. According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours）, the subjects enrolled have at least one measurable neoplasm lesion.
6. 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.

Exclusion Criteria:

1. 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.
2. Major surgery or other treatment or diagnosis that has a significant impact on the subject within 4 weeks before the first dose.
3. Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.
4. History of severe cardiovascular and cerebrovascular disorder.
5. Active infectious disease.
6. History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
7. Women during pregnancy or lactation.
8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Where this trial is running

Fuzhou, Fujian and 14 other locations

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

Study contacts

• Principal investigator: Yu Chen — Fujian Cancer Hospital
• Study coordinator: Yu Chen

Conditions Advanced Melanoma