Evaluating LBL-007 with Toripalimab and Axitinib for Advanced Melanoma

A Phase I Multi-center Study to Evaluate the Safety ,Tolerability and Efficacy of LBL-007 Combined With Toripalimab or LBL-007 Combined With Toripalimab and Axitinib Tablets in the Treatment of Unresectable or Metastatic Melanoma

This study is testing a new treatment combining LBL-007, Toripalimab, and Axitinib to see if it helps people with advanced melanoma feel better and stay safe during the process.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (Industry-sponsored)
• Drugs / interventions: Toripalimab, Axitinib
• Locations: 8 sites (Beijing, Beijing and 7 other locations)
• Trial ID: NCT04640545 on ClinicalTrials.gov

What this trial studies

This phase I clinical trial is designed to assess the safety and efficacy of LBL-007 in combination with Toripalimab and Axitinib for patients with advanced melanoma. The study is structured into two parts: a dose-escalation phase and a dose-expansion phase, where participants will receive the treatment and be monitored for safety, tolerability, and preliminary effectiveness. The trial aims to gather data on the pharmacokinetics and immunogenicity of the treatment regimen in subjects with unresectable or metastatic melanoma.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with advanced melanoma who have at least one measurable tumor lesion.

Not a fit: Patients with active central nervous system metastases or allergies to the study drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced melanoma.

How similar studies have performed: Other studies have shown promise with similar immunotherapy combinations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Willingness to provide written informed consent and follow the study treatment plan and visit plan;
2. Aged ≥ 18 years at time of signing informed consent, male or female;
3. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;
4. Have life expectancy of at least 12 weeks ;
5. Subject with at least one measurable tumor lesion,according to the evaluation standard of solid tumor efficacy (RECIST 1.1).

Exclusion criteria:

1. Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in the prescription;
2. Subjects with active central nervous system metastases (regardless of whether they have received treatment), including symptomatic brain metastases, meningeal metastases, or spinal cord compression, but asymptomatic brain metastases (no progression and/or at least 4 weeks after radiotherapy) No neurological symptoms or signs after surgical resection, and dexamethasone or mannitol treatment is not required);
3. Have received major surgery within 4 weeks before the first administration;
4. Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding);
5. Women during pregnancy or lactation;

Where this trial is running

Beijing, Beijing and 7 other locations

• Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
• Jilin Cancer Hospital — Changchun, Jilin, China (Recruiting)
• the First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Jun Guo, Prof — Peking University Cancer Hospital & Institute
• Study coordinator: Xiangyu Ma

Conditions Advanced Melanoma