ZN-c3 in Adult Participants With BRAF mutant Metastatic Colorectal Cancer

计划状态

活跃,非招募

阶段

第 1 阶段

允许先接受免疫治疗

CRC 指导的试验

药物

cetuximab, encorafenib, ZN-c3

标签

MSI-H/ MMRd、MSS/ MMRp

评论

Only for patients with metastatic BRAF V600E mutant colorectal cancer. Must have been previously treated with one or two treatment regimens.

ZN-c3: azenosertib; experimental Wee1 inhibitor. Oral.

Encorafenib: small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway (Braftovi®). Oral.

Cetuximab: (Erbitux®) epidermal growth factor receptor (EGFR) inhibitor. Intravenous.

地点 位置状态
美国
USC Norris Comprehensive Cancer Center
加利福尼亚州洛杉矶 90033
活跃,非招募
Alliance for Multispecialty Research, LLC
Merriam, Kansas 66204
活跃,非招募
得克萨斯大学 MD 安德森癌症中心
德克萨斯州休斯顿 77030
活跃,非招募
澳大利亚
伊丽莎白医院
伍德维尔南,南澳大利亚州 5011
活跃,非招募
彼得-麦克卡勒姆癌症中心
墨尔本,维多利亚 3000
活跃,非招募
德国
Hämatologie- Onkologie im Zentrum MVZ GmbH
Augsburg, Bayern 86150
活跃,非招募
Klinikum der Universität München Großhadern
Muenchen, Bayern 81377
活跃,非招募
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
Muenchen, Bayern 81737
活跃,非招募
Institut für Klinisch Onkologische Forschung
Frankfurt, Hessen 60488
活跃,非招募
DRK Kliniken Berlin - Köpenick
Berlin 12559
活跃,非招募
Hungary
Semmelweis University-Department of Internal Medicine and Oncology
Budapest 1083
活跃,非招募
Clinexpert Kft. Bugat Pal Korhaz
Gyöngyös 3200
活跃,非招募
意大利
Istituto Nazionale Tumori IRCCS Fondazione Pascale
坎帕尼亚,那不勒斯 80131
活跃,非招募
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia 71013
活跃,非招募
AOUI Verona
Verona, Veneto 37126
活跃,非招募
欧洲肿瘤研究所
Milano 20141
活跃,非招募
ASST Grande Ospedale Metropolitano Niguarda
米兰 20162
活跃,非招募
波兰
Szpital Uniwersytecki w Krakowie
Kraków, Malopolskie 31-501
活跃,非招募
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Kraków, Malopolskie 31-826
活跃,非招募
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Mazowieckie 02-034
活跃,非招募
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
Opole, Opolskie 45-061
活跃,非招募
西班牙
Parc de Salut Mar - Hospital del Mar
Barcelona, Cataluna 08003
活跃,非招募
索菲亚王后大学医院
Córdoba, Cordoba 14004
活跃,非招募
Fundación Instituto Valenciano de Oncología
Valencia, Valenciana, Comunitat 46009
活跃,非招募
瓦尔德希伯伦大学医院
巴塞罗那 08035
活跃,非招募
拉巴斯大学医院
马德里 28046
活跃,非招募
Hospital Universitario Puerta de Hierro Majadahonda
Madrid 28222
活跃,非招募

纳入标准

纳入标准

* Histologically or cytologically confirmed metastatic Stage IV colorectal adenocarcinoma.
* Documented evidence of a BRAF V600E mutation in tumor tissue or blood
* Presence of measurable disease per RECIST version 1.1 guidelines.
* Disease progression after 1 or 2 previous systemic regimens for metastatic disease
* Adequate bone marrow function
* Adequate hepatic and renal function

排除标准

排除标准:

* Documented clinical disease progression or radiographic disease progression during the screening period
* 脑膜病。
* Symptomatic brain metastasis.
* Presence of acute or chronic pancreatitis.
* Unable to swallow, retain, and absorb oral medications.
* Clinically significant cardiovascular diseases
* Evidence of active noninfectious pneumonitis.
* Evidence of active and uncontrolled bacterial or viral infection, within 2 weeks prior to start of any of the study interventions
* Participants with known positivity for HIV
* Active hepatitis B or hepatitis C infection
* Concurrent or previous other malignancy within 2 years of study entry
* Has had an allogeneic tissue/solid organ transplant
* Pregnant or females of childbearing potential who have a positive β-hCG laboratory test result within 14 days prior to enrollment or is breastfeeding

NCT ID

NCT05743036

添加审判日期

2023-02-24

更新日期

2025-03-25