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

Официальное название

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[Substudy Number 02(BTC&HCC)]

Обзор

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.

Подробное описание

This trial is an open-label, multicenter, phase II clinical study of LBL-024 in combination with other drugs for the treatment of patients with Advanced biliary tract cancer (BTC) and hepatocellular carcinoma (HCC), to evaluate the efficacy and safety of LBL-024 combination therapy.The trial included two cohorts.

Cohort 1: This cohort will have a safety run-in period,a small number of subjects will be enrolled to receive LBL-024 Combination Administration. After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If the safety and tolerability are good, the extension study of combination administration will be continued, the subjects will be continued to be enrolled.

Cohort 2: This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration. After completing the 21-day safety observation, the safety and tolerability of the combination drugs will be assessed. The sponsor and investigator assessed the safety and tolerability of the combination drugs as good,and then the cohort will continue to enroll subjects,the extension study of combination administration will be continued.

The trial will enroll up to 140 subjects.

Вмешательства

• Препарат LBL-024 for Injection
  Intravenous infusion.
• Препарат Cisplatin Injection
  Intravenous infusion.
• Препарат Gemcitabine Hydrochloride for Injection
  Intravenous infusion.
• Препарат Bevacizumab Injection
  Intravenous infusion.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]

Вторичные конечные точки (5)

• Disease Control Rate(DCR） [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Duration of Response(DOR） [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Cmax [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Tmax [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• immunogenicity [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]

Критерии участия

Критерии включения

• 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.
• Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
• The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
• The expected survival time is at least 12 weeks.
• According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable lesion.
• There is adequate organ and bone marrow function,Conforms to laboratory test results.
• 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.

Критерии исключения

• Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or Subject is expected to receive any other form of systemic or local anti-tumor therapy outside the protocol during the study.
• Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
• Patients with active infection and requiring intravenous anti-infective therapy within 2 weeks before the first dose.
• Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
• The patient has a Medical history of immunodeficiency, including HIV antibody positive.
• Women during pregnancy or lactation.
• History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism or drug addiction.
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 8 центров

• The First Affiliated Hospital of Guangxi Medical University — Nanning
• Henan Cancer Hospital — Чжэнчжоу
• Xiangyang Central Hospital — Xiangyang
• Jiangxi Cancer Hospital — Nanchang
• Shandong Cancer Hospital — Цзинань
• Zhongshan Hospital of Fudan University — Шанхай
• Sir Run Run Shaw Hospital (SRRSH) Zhejiang University School of Medicine — Ханчжоу
• Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT07111546 · LBL-024-CN004_02(BTC & HCC)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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