A Phase Ib/Ⅱ Clinical Trial of LBL-024 Combined With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer

Официальное название

An Open-label, Multicenter Phase Ib/Ⅱ Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Paclitaxel Injection in Patients With Platinum-resistant Ovarian Cancer

Обзор

This trial is an open-label, multicenter phase Ib/II clinical study of LBL-024 combination therapy in patients with platinum-resistant ovarian cancer (OC),To evaluate the efficacy and safety of LBL-024 combination therapy in the treatment of advanced recurrent platinum-resistant ovarian cancer (OC) patients.

Подробное описание

The trial was divided into two phases.

Stage I (Phase Ib): Single-Arm Safety Lead-In Period. In this stage, a small number of subjects were enrolled first and received LBL-024 combined with paclitaxel treatment, with 21 days as a cycle.Safety, tolerability and preliminary efficacy of combination drugs were assessed by the sponsor and investigators.LBL-024 Dose De-escalation Principle Based on Safety and Tolerability.

Stage II (Phase II) Randomized, Expansion Cohort Study. If safety and tolerability are good, the combined administration extension study will be continued. Subjects were continued to be enrolled in the study. The study was designed as a randomized, open-label, positive-controlled trial.Subjects who met the criteria were randomly assigned to the experimental group and the control group in a ratio of 2: 1.Experimental group (LBL-024 combined with paclitaxel) and Control group (paclitaxel monotherapy).

This study will enroll up to 110 subjects.

Вмешательства

• Препарат LBL-024 for Injection
  LBL-024 Intravenous infusion.
• Препарат Paclitaxel Injection
  Paclitaxel 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)]
• Occurrence of adverse event (AE) and serious adverse event (SAE) [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Progression-free Survival(PFS) [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)

• 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)]
• 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)]

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.
• At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.
• 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 （Response Evaluation Criteria in Solid Tumours），the subjects enrolled have at least one measurable lesion.
• 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;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

• The subject is currently participating in any other clinical trial,Or has received or is receiving other investigational agents within 4 weeks prior to the first dose of study drug.
• Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.
• Patients with active infection and currently requiring systemic treatment. active pulmonary tuberculosis (TB), receiving anti-tuberculosis treatment or Received anti-tuberculosis treatment within 6 months before screening.
• Patients with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.
• The patient has a Medical history of immunodeficiency, including HIV antibody positive.
• Active hepatitis B or active hepatitis C.
• Women during pregnancy or lactation.
• History of mental and/or psychiatric illness (impairing 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 13 центров

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Пекин
• Beijing Obstetrics and Gynecology Hospital Capital Medical University — Пекин
• Fujian Cancer Hospital — Фучжоу
• Sun Yat-sen University Cancer Center — Гуанчжоу
• Harbin Medical University Cancer Hospital — Харбин
• AnYang Tumor Hospital — Anyang
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou
• … и ещё 5 центров

Идентификаторы

NCT: NCT07042802 · LBL-024-CN006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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