A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma

Launched by NANJING LEADS BIOLABS CO.,LTD · Nov 17, 2020

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ClinConnect Summary

This clinical trial is investigating a new treatment called LBL-007, which is being tested alongside two existing medications, Toripalimab and Axitinib, for patients with advanced melanoma, a type of skin cancer that has spread. The study aims to find out if this combination can help improve treatment outcomes for individuals facing this challenging condition. The trial is currently recruiting participants who are at least 18 years old and have a life expectancy of at least 12 weeks. To be eligible, participants need to have at least one measurable tumor and a good performance status, meaning they are generally well enough to participate.

If you join this trial, you will receive the study treatment and be closely monitored by the medical team during your visits. The trial will help researchers learn more about how effective LBL-007 is when combined with the other medications. However, certain individuals are not eligible, including those with severe allergies to the study drugs, those with specific types of brain metastases, or those who have had major surgery recently. If you're interested in participating, it’s important to discuss this with your doctor, who can help determine if this study is right for you.

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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;