Первое исследование на людях препарата BG-C0979 у взрослых пациентов с распространенными солидными опухолями
Многоцентровое, открытое, исследование фазы 1a/1b первого применения на людях для изучения безопасности, переносимости, фармакокинетики и предварительной противоопухолевой активности препарата BG-C0979 у пациентов с выбранными распространенными солидными опухолями
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 1
Контакты и местонахождение
Контакты исследования
- Имя: Study Director
- Номер телефона: 8778285568
- Электронная почта: clinicaltrials@beonemed.com
Места учебы
-
-
New South Wales
-
Frenchs Forest, New South Wales, Австралия, NSW 2086
- Рекрутинг
- Northern Beaches Hospital
-
Liverpool, New South Wales, Австралия, NSW 2170
- Рекрутинг
- Liverpool Hospital
-
-
Queensland
-
South Brisbane, Queensland, Австралия, QLD 4101
- Рекрутинг
- Icon Cancer Centre South Brisbane
-
-
Victoria
-
Malvern, Victoria, Австралия, VIC 3144
- Рекрутинг
- Cabrini Hospital Malvern
-
-
-
-
-
Barcelona, Испания, 08036
- Рекрутинг
- Hospital Clinic de Barcelona
-
Barcelona, Испания, 08035
- Рекрутинг
- Hospital Universitario Vall Dhebron
-
Madrid, Испания, 28040
- Рекрутинг
- Hospital Universitario Fundacion Jimenez Diaz
-
Madrid, Испания, 28223
- Рекрутинг
- Next Oncology Madrid
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Китай, 100021
- Рекрутинг
- Cancer Hospital Chinese Academy of Medical Sciences
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Китай, 400037
- Рекрутинг
- Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
-
-
Fujian
-
Fuzhou, Fujian, Китай, 350028
- Рекрутинг
- Mengchao Hepatobiliary Hospital of Fujian Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, Китай, 510245
- Рекрутинг
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
-
-
Hubei
-
Yichang, Hubei, Китай, 443003
- Рекрутинг
- Yichang Central Peoples Hospital
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Китай, 201321
- Рекрутинг
- Fudan University Shanghai Cancer Centerpudong
-
-
-
-
Massachusetts
-
Boston, Massachusetts, Соединенные Штаты, 02215-5418
- Рекрутинг
- Dana Farber Cancer Institute
-
-
Missouri
-
St Louis, Missouri, Соединенные Штаты, 63110-1010
- Рекрутинг
- Washington University School of Medicine
-
-
New Jersey
-
Hackensack, New Jersey, Соединенные Штаты, 07601
- Рекрутинг
- John Theurer Cancer Center Hackensack University Medical Center
-
-
Texas
-
San Antonio, Texas, Соединенные Штаты, 78229
- Рекрутинг
- Next Oncology San Antonio
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.
- Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have adequate organ function.
Exclusion Criteria:
- Prior treatment with any ADAM9 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Последовательное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Phase 1a: Monotherapy Dose Escalation
Participants will receive increasing doses of BG-C0979 as monotherapy. |
Administered by intravenous infusion. |
|
Экспериментальный: Phase 1a: Monotherapy Safety Expansion
Participants will receive BG-C0979 as monotherapy. Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in safety expansion. |
Administered by intravenous infusion. |
|
Экспериментальный: Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion
Participants will receive BG-C0979 as monotherapy in a dose optimization and dose expansion phase at different dose levels of recommended doses for expansion (RDFEs) identified in Phase 1a. |
Administered by intravenous infusion. |
|
Экспериментальный: Phase 1b, Part B: Combination Therapy Expansion
Participants will receive BG-C0979 in combination with tislelizumab in select tumor types. |
Administered by intravenous infusion. Administered by intravenous infusion.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Временное ограничение: Up to approximately 24 months
|
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including dose limiting toxicities (DLTs), AEs meeting protocol-defined adverse event of clinical interest (AECI) criteria, laboratory values, and electrocardiogram results. |
Up to approximately 24 months
|
|
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy
Временное ограничение: Up to approximately 10 months
|
MTD or MAD, defined as the highest dose for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively. |
Up to approximately 10 months
|
|
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s])
Временное ограничение: Up to approximately 10 months
|
The potential RDFE(s) of BG-C0979 will be determined based on the totality of data including the MTD or MAD, long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available. |
Up to approximately 10 months
|
|
Phase 1b: Recommended Phase 2 Dose (RP2D)
Временное ограничение: Up to approximately 24 months
|
RP2D of BG-C0979 alone and in combination with tislelizumab will be determined based on safety, PK, preliminary antitumor activity, and other relevant data, as available. |
Up to approximately 24 months
|
|
Phase 1b: Overall Response Rate (ORR)
Временное ограничение: Up to approximately 24 months
|
ORR as determined from tumor assessment by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For castration-resistant prostate cancer (CRPC), ORR will be assessed by RECIST v1.1 criteria for soft tissue and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR). |
Up to approximately 24 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Фаза 1a: Концентрация BG-C0979 в плазме
Временное ограничение: До приблизительно 3 месяцев
|
До приблизительно 3 месяцев
|
|
|
Фаза 1a: Площадь под кривой «концентрация-время» (AUC) для BG-C0979
Временное ограничение: До приблизительно 3 месяцев
|
До приблизительно 3 месяцев
|
|
|
Фаза 1a: Максимальная наблюдаемая концентрация (Cmax) BG-C0979
Временное ограничение: До приблизительно 3 месяцев
|
До приблизительно 3 месяцев
|
|
|
Фаза 1а: Время достижения максимальной концентрации (Tmax) препарата BG-C0979
Временное ограничение: До приблизительно 3 месяцев
|
До приблизительно 3 месяцев
|
|
|
Фаза 1b: Концентрация BG-C0979 в плазме крови, отдельно и в комбинации с тизелизумабом
Временное ограничение: До приблизительно 3 месяцев
|
До приблизительно 3 месяцев
|
|
|
Phase 1a: ORR
Временное ограничение: Up to approximately 24 months
|
ORR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, ORR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR). |
Up to approximately 24 months
|
|
Phase 1a and 1b: Duration of Response (DOR)
Временное ограничение: Up to approximately 24 months
|
DOR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DOR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
|
|
Phase 1a and 1b: Disease Control Rate (DCR)
Временное ограничение: Up to approximately 24 months
|
DCR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DCR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DCR is defined as the percentage of participants with best overall response of a CR, PR, or stable disease. |
Up to approximately 24 months
|
|
Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
Временное ограничение: Up to approximately 24 months
|
Number of participants with TEAEs and SAEs, including AECIs, laboratory values, and electrocardiogram results. |
Up to approximately 24 months
|
|
Phase 1b: Progression-Free Survival
Временное ограничение: Up to approximately 24 months
|
PFS is defined as the time from the date of the first administration of study drug(s) to the date of the first documentation of disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
|
|
Phase 1b: Radiographic Progression-Free Survival (rPFS) for Participants with CRPC
Временное ограничение: Up to approximately 24 months
|
rPFS is defined as the time from the date of the first administration of study drug(s) to the date of the first objective evidence of radiographic disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
|
|
Prostate-Specific Antigen (PSA) Response for Participants with CRPC
Временное ограничение: Up to approximately 24 months
|
PSA response is defined as a ≥50% decrease in PSA level from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later. |
Up to approximately 24 months
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Study Director, BeOne Medicines
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- BG-C0979-101
- 2025-524857-15-00 (Ктис)
- CTR20261327 (Другой идентификатор: ChinaDrugTrials)
- 2025 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Сроки обмена IPD
See plan description
Критерии совместного доступа к IPD
See plan description
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .