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Recruiting Phase 1, Phase 2 NCT07099430

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

Trial Parameters

Condition Advanced Melanoma
Sponsor Nanjing Leads Biolabs Co.,Ltd
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-09-05
Completion 2027-10-30
Interventions
LBL-024 for InjectionLBL-007 InjectionToripalimab Injection

Brief 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 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 planne

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