计划状态
招聘阶段
第 1 阶段允许先接受免疫治疗
没有CRC 指导的试验
是药物
HRO761, Irinotecan标签
MSI-H/ MMRd| 地点 | 位置状态 |
|---|---|
| 美国 | |
|
University of California LA 加利福尼亚州洛杉矶 90095 |
招聘 |
|
UCSF 加利福尼亚州旧金山 94115 |
招聘 |
|
达纳法伯癌症研究所 马萨诸塞州波士顿 02215 |
招聘 |
|
Memorial Sloan Kettering New York, New York 10017 |
招聘 |
|
Columbia University Medical Ctr 纽约州纽约市 10032 |
招聘 |
|
Univ of TX MD Anderson Cancer Cntr 德克萨斯州休斯顿 77030 |
招聘 |
| 比利时 | |
|
Novartis Investigative Site 布鲁塞尔 1200 |
招聘 |
| 中国 | |
|
Novartis Investigative Site Beijing 100036 |
招聘 |
|
Novartis Investigative Site Guangzhou 510655 |
招聘 |
| 法国 | |
|
Novartis Investigative Site 波尔多 33076 |
招聘 |
|
Novartis Investigative Site Marseille 13273 |
招聘 |
| 德国 | |
|
Novartis Investigative Site Essen 45147 |
招聘 |
|
Novartis Investigative Site 乌尔姆 89081 |
招聘 |
| 以色列 | |
|
Novartis Investigative Site 特拉维夫 6423906 |
招聘 |
| 意大利 | |
|
Novartis Investigative Site Milano, MI 20162 |
招聘 |
|
Novartis Investigative Site Rozzano, MI 20089 |
招聘 |
| 日本 | |
|
Novartis Investigative Site Kashiwa, Chiba 277 8577 |
招聘 |
| 大韩民国 | |
|
Novartis Investigative Site 首尔 03722 |
招聘 |
| 挪威 | |
|
Novartis Investigative Site 奥斯陆 0310 |
招聘 |
| 新加坡 | |
|
Novartis Investigative Site 新加坡 119228 |
招聘 |
| 西班牙 | |
|
Novartis Investigative Site 巴塞罗那，加泰罗尼亚 08035 |
招聘 |
|
Novartis Investigative Site Valencia, Comunidad Valenciana 46010 |
招聘 |
|
Novartis Investigative Site 马德里 28009 |
招聘 |
|
Novartis Investigative Site 马德里 28040 |
招聘 |
| 瑞典 | |
|
Novartis Investigative Site Stockholm 17176 |
招聘 |
| 台湾 | |
|
Novartis Investigative Site 台北 10002 |
招聘 |
| 英国 | |
|
Novartis Investigative Site 伦敦 SW3 6JJ |
招聘 |
|
Novartis Investigative Site Oxford OX3 7LE |
招聘 |
联系方式
纳入标准
Key Inclusion criteria:
* Patients with advanced unresectable or metastatic MSIhi or MMR deficient (dMMR) solid tumors who have progressed after or are intolerant to prior standard therapy.
* Arm A and C: Patients must have progressed on the most recent therapy for advanced disease including one prior line of immune checkpoint inhibitor therapy.
* Arm B: Patients should have received prior chemotherapy or targeted therapy, and patients should have received prior immune checkpoint inhibitor or should be expected to benefit from immune checkpoint inhibitor therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
* Measurable disease as determined by RECIST version 1.1
* HRO761 s.a. (Arm A) dose finding only: Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at screening, and during therapy on the study. A biopsy from the same lesion is preferred if safe and medically feasible. Exceptions may be considered after documented discussion with Novartis.
* All patients (Arm A, B and C) will have available archival tumor tissue obtained prior to study treatment initiation (in addition to newly obtained tumor biopsy at screening for Arm A), to allow retrospective MSIhi/dMMR status confirmation.
钥匙
排除标准
Exclusion criteria:
* Impaired cardiac function or clinically significant cardiac disease
* Clinically significant eye impairment
* Patients with a primary Central Nervous System (CNS) tumor or tumor metastatic to the CNS
* Human Immunodeficiency Virus (HIV) infection
* Active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Tuberculosis infection. Patients whose disease is controlled under antiviral therapy should not be excluded.
* History of severe hypersensitivity reactions to any ingredient of study drug(s)
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., severe ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection), except for prior gastrectomy.
Other protocol-defined inclusion/exclusion criteria may apply
