A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors

Официальное название

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors

Обзор

To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors

Подробное описание

This trial is a single-arm, open-label, phase I/II clinical study of LBL-024 in patients with advanced malignant tumors. The phase I dose escalation and PK expansion phase plans to include patients with advanced malignant tumors who have failed previous standard treatment or do not have standard treatment or are not applicable to standard treatment at this stage. The phase IIa indication expansion phase plans to include patients with advanced malignant tumors , and evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity and preliminary efficacy. Single-arm registry clinical study to be conducted in Phase IIb.

This trial includes two parts:

Part I: A Phase I/IIa clinical study on the safety, tolerability, PK and efficacy of LBL-024 in patients with advanced malignant tumor.

Part II:Phase IIb is a pivotal single-arm clinical study.

Вмешательства

• Препарат LBL-024 for Injection
  LBL-024 was given every three weeks for treatment

Первичные конечные точки

• Maximum tolerated dose (MTD) [Срок оценки: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）]
• Dose-limiting toxicities（DLT) [Срок оценки: Within 3 weeks after receiving the first dose of the test drug]
• Objective Response Rate (ORR) [Срок оценки: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）]

Вторичные конечные точки (5)

• Adverse events and serious adverse events [Срок оценки: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）]
• Maximum serum concentration (Cmax) [Срок оценки: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）]
• Immunogenicity [Срок оценки: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）]
• Disease Control Rate(DCR) [Срок оценки: Visit 30 days after discontinuation of treatment or withdraw from the visit]
• Progression-free survival (PFS) [Срок оценки: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal（Visit 30 days after discontinuation of treatment or withdraw from the visit）]

Критерии участия

Критерии включения

• Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
• 18-75 years old (including boundary value), no gender limit in the I/IIa trial phase；18-80 years old (including boundary value), no gender limit in the IIb trial phase；
• Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
• The expected survival time is at least 12 weeks
• ECOG score is 0-1
• 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 (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.

Критерии исключения

• Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
• Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment;
• medical history of immunodeficiency including positive HIV antibody test;
• Women who are pregnant or breastfeeding;
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the 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 · 49 центров

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• Anhui Provincial Hospital — Хэфэй
• The Second Hospital of Anhui Medical University — Хэфэй
• Peking Union Medical College Hospital — Пекин
• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Beijing Cancer Hospital — Пекин
• Chongqing Cancer Hospital — Чунцин
• Fujian Cancer Hospital — Фучжоу
• … и ещё 41 центр

Идентификаторы

NCT: NCT05170958 · LBL-024-CN001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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