A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer

Официальное название

An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 Monotherapy or in Combination With Albumin-bound Paclitaxel in Patients With Recurrent or Metastatic Triple Negative Breast Cancer

Обзор

This trial is an open-label, multicenter phase Ib/II clinical study to evaluate the efficacy and safety of LBL-024 monotherapy or in combination with albumin-bound paclitaxel in patients with recurrent or metastatic triple negative breast cancer(TNBC).

Подробное описание

The trial was divided into two phases.

Stage I (Phase Ib):

Part A: Monotherapy Period:In the phase Ib Part A monotherapy period, a small number of TNBC patients were planned to be enrolled to receive LBL-024 monotherapy.The safety, tolerability, and preliminary efficacy of LBL-024 monotherapy in this population will be assessed by the sponsor and investigator in combination.

Part B: Combination Drug Safety Run-In Period:If the safety and tolerability are good and there is preliminary efficacy in Part A,The investigator discussed with the sponsor to decide whether to continue the study in Part B of Phase Ib.Part B is designed to enroll a small number of TNBC patients to receive LBL-024 combination therapy.

Stage II (Phase II) ： If the safety and tolerability are good and there is preliminary efficacy in the first stage,The investigator discusses with the sponsor to decide whether to continue the co-administration expansion study, continue to enroll TNBC patients, and using a randomized, open, positive control trial design.

This study will enroll up to 220 subjects.

Вмешательства

• Препарат LBL-024 for Injection
  Intravenous infusion.
• Препарат albumin-bound Paclitaxel injection
  Intravenous infusion.
• Препарат Toripalimab 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)]
• 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.
• 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 must have a negative pregnancy test within 7 days before the first trial drug is administered.Male patients 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,and do not donate sperm during this period.

Критерии исключения

• Use of immunomodulatory drugs within 2 weeks prior to first dose of study drug.
• Patients who received live vaccination within 4 weeks before the first dose of study drug or who are scheduled to receive live vaccination during the study treatment period and within 4 weeks after the last dose.
• Patients with clinically uncontrolled pleural effusion, peritoneal effusion, or pericardial effusion.
• Active infection within 2 weeks prior to first dose of study drug.
• Active infectious disease.
• Women with plans for pregnancy,Or women who are pregnant or breastfeeding.
• Active hepatitis B or active hepatitis C.
• 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.

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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 · 7 центров

• Sun Yat-sen University Cancer Center — Гуанчжоу
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Гуанчжоу
• Harbin Medical University Cancer Hospital — Харбин
• Henan Cancer Hospital — Чжэнчжоу
• Jiangsu Province Hospital — Нанкин
• The first hospital of Jilin University — Changchun
• Liaoning Cancer Hospital — Шэньян

Идентификаторы

NCT: NCT07281976 · LBL-024-CN005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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