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Recruiting Phase 2 NCT07111546

A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)]

Trial Parameters

Condition Advanced Solid Tumour
Sponsor Nanjing Leads Biolabs Co.,Ltd
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 140
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-10-20
Completion 2027-12-26
Interventions
LBL-024 for InjectionCisplatin InjectionGemcitabine Hydrochloride for Injection

Brief Summary

An open-label, multicenter, phase II clinical study to evaluate the efficacy and safety of LBL-024 in combination with other drugs for the treatment of patients with advanced solid tumour.

Eligibility Criteria

Inclusion Criteria: 1. Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent. 2. Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form. 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 standard, the subjects enrolled have at least one measurable lesion. 6. There is adequate organ and bone marrow function,Conforms to laboratory test results. 7. Males with fertility and females of childbearing age are willing to take 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. Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of s

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