An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer.

计划状态

活跃,非招募

阶段

第 1 阶段 第二阶段

允许先接受免疫治疗

没有

CRC 指导的试验

药物

AB680, Bevacizumab, Etrumadenant, mFOLFOX-6 regimen, Regorafenib, Zimberelimab

标签

MSS/ MMRp

评论

No prior anti PD-1 allowed
Patients with BRAF mutation are excluded

地点 位置状态
美国
Arizona Clinical Research Center Inc
Tucson, Arizona 85715
活跃,非招募
City of Hope Comprehensive Cancer Center
加利福尼亚州杜阿尔特 91010
活跃,非招募
UCLA Hematology Oncology
Santa Monica, California 90404
活跃,非招募
耶鲁大学癌症中心
康涅狄格州纽黑文 06510
活跃,非招募
西伯利纪念医院
Washington, District of Columbia 20016-2633
活跃,非招募
Winship Cancer Institute at Emory University
佐治亚州亚特兰大 30322
活跃,非招募
Ochsner Medical Center (OMC)
New Orleans, Louisiana 70121
活跃,非招募
American Oncology Partners of Maryland PA
Bethesda, Maryland 20817
活跃,非招募
华盛顿大学医学院
密苏里州圣路易斯 63110
活跃,非招募
内华达综合癌症中心
内华达州拉斯维加斯 89169
活跃,非招募
NYU Langone Medical Center - NYU Medical Oncology Associates
纽约州纽约市 10016
活跃,非招募
New York-Presbyterian Hospital-Columbia University Medical Center
纽约州纽约市 10032
活跃,非招募
Prisma Health-Upstate
南卡罗来纳州格林维尔 29605
活跃,非招募
Vanderbilt-Ingram Cancer Center
田纳西州纳什维尔 37203
活跃,非招募
萨拉-坎农研究所
田纳西州纳什维尔 37232
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
University of Wisconsin School of Medicine
威斯康星州麦迪逊 53792
活跃,非招募
法国
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
波尔多 33076
活跃,非招募
Centre Georges Francois Leclerc
第戎 21000
活跃,非招募
Hopital Hotel Dieu
Nantes Cedex 1 44093
活跃,非招募
Groupe Hospitalier Pitie-Salpetriere-Centre De Recherche et de Medecine de l'Obesite
Paris Cedex 13 75651
活跃,非招募
Hopital Saint Antoine
Paris 75012
活跃,非招募
CHU la Miletrie
Poitiers 86000
活跃,非招募
意大利
IRCCS - Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Castellana Grotte 70013
活跃,非招募
Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica
佛罗伦萨 50134
活跃,非招募
Azienda Ospedaliera Niguarda Ca' Granda
Milano 20141
活跃,非招募
Instituto Europeo di Oncologia
米兰 20162
活跃,非招募
Istituto Clinico Humanitas IRCCS
Rozzano 20089
活跃,非招募
Universita di Siena - Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena 53100
活跃,非招募
大韩民国
Chonnam National University Hwasun Hospital
Hwasun 58128
活跃,非招募
Seoul National University Bundang Hospital
Seoul 13620
活跃,非招募
Seoul National University Hospital (SNUH)
Seoul 3080
活跃,非招募
Severance Hospital | Yonsei University Health System
Seoul 3722
活跃,非招募
Asan Medical Center | University of Ulsan College of Medicine
Seoul 5538
活跃,非招募
三星医疗中心
Seoul 6351
活跃,非招募
Korea University Anam Hospital
Seoul 8241
活跃,非招募
Kyungpook National University Chilgok Hospital
Seoul
活跃,非招募
西班牙
拉巴斯大学医院
Madrid 28007
活跃,非招募
Hospital General Universitario Gregorio Maranon
马德里 28046
活跃,非招募
Complejo Hospitalario de Orense
Orense 32005
活跃,非招募
Clinica Universidad Navarra-Sede Madrid
潘普洛纳 31008
活跃,非招募
Corporacio Sanitaria Parc Tauli
Sabadell 08208
活跃,非招募
英国
Belfast City Hospital
Belfast, Northern Ireland BT9 7AB
活跃,非招募
Aberdeen Royal Infirmary
Aberdeen, Scotland AB25 2ZN
活跃,非招募

纳入标准

纳入标准

* Male and female participants ≥ 18 years of age
* Histologically confirmed metastatic colorectal adenocarcinoma
* Must have at least 1 measurable lesion per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy at least 3 months
* Adequate hematologic and end-organ function
* Negative HIV, Hep B and Hep C antibody testing
* Agreement to remain abstinent or use contraceptive measures with female partners of reproductive potential, and agreement to refrain from donating sperm, for 30 days after the last dose of etrumadenant, 90 days after the last dose of zim, 180 days after mFOLFOX-6 and 180 days after bev, whichever is longer.

* Inclusion Criteria for Cohort A:
* Disease progression following not more than one prior line of treatment for mCRC that consisted of oxaliplatin or irinotecan containing chemotherapy in combination with a biologic agent

* Inclusion Criteria for Cohort B:
* Disease progression during or following not more than two separate lines of treatment for mCRC that consisted of oxaliplatin, and irinotecan containing chemotherapy in combination with a biologic agent

排除标准

排除标准:

* Previous anticancer treatment within 4 weeks prior to initiation of study treatment
* Prior allogeneic stem cell or solid organ transplant
* Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment
* Use of any live vaccines against infectious diseases within 28 days of first dose.
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Current treatment with anti-viral therapy for HBV
* Structurally unstable bone lesions suggesting impending fracture
* History or leptomeningeal disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
* History of malignancy other than colorectal cancer within 2 years prior to screening, except for malignancies such as non-melanoma skin carcinoma or ductal carcinoma in situ
* Active tuberculosis
* Treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiating study treatment
* Severe infection within 4 weeks (28 days) prior to initiation of study treatment
* Significant cardiovascular disease, unstable or new onset of angina within 3 months prior to initiation of treatment, or myocardial infarction within 6 months prior to study treatment or unstable arrhythmia
* Major surgical procedures, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for major surgical procedure during the study
* Known allergy or hypersensitivity to any of the study drugs or their excipients
* Inability to swallow medications
* Malabsorption condition that would alter the absorption of orally administered medications
* Evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)
* Prior treatment with an agent targeting the adenosine pathway
* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain Barré syndrome, or multiple sclerosis

* Exclusion Criteria for Cohorts A and B:
* Prior treatment with immune checkpoint blockade therapies including anti-cytotoxic T lymphocyte-associated protein-4, anti PD-1, and anti-PD-L1 therapeutic antibodies
* Mutation in the BRAF oncogene. Patients with unknown BRAF status will be required to undergo testing at a local laboratory and provide results at screening

NCT ID

NCT04660812

添加审判日期

2020-12-09

更新日期

2025-06-27