计划状态
活跃，非招募阶段
第 1 阶段允许先接受免疫治疗
是CRC 指导的试验
是药物
Adagrasib, INCB099280标签
MSI-H/ MMRd、MSS/ MMRp评论
Only for patients with KRASG12C-mutated solid malignancy, like colon or rectal KRAS G12C mutant cancer. Both MSS and MSI-H are included.
For MSI-H patients, prior anti PD-1/PD-L1 is *required* (is not only allowed but it is required that they have received prior immunotherapy).
INCB099280 in combination with adagrasib. Both are ORAL agents.
INCB099280：检查点抑制剂，抗 PD-L1。口服免疫疗法。其他获批的抗PD-L1抑制剂--atezolizumab（Tecentriq）、avelumab（Bavencio）、durvalumab（Imfinzi）--均为静脉注射。
adagrasib: KRAS G12C inhibitor, Krazati®. Oral.
Check updated locations at https://classic.clinicaltrials.gov/ct2/show/NCT06039384#contacts
有用链接
https://www.esmoiotech.org/article/S2590-0188(23)00352-0/fulltext https://www.annalsofoncology.org/article/S0923-7534(22)03898-4/fulltext| 地点 | 位置状态 |
|---|---|
| 美国 | |
|
Valkyrie 临床试验 加利福尼亚州洛杉矶 90067 |
活跃，非招募 |
|
Banner Md Anderson Cancer Center Greeley, Colorado 80631 |
活跃，非招募 |
|
亨利福特医疗系统 密歇根州底特律 48202 |
活跃，非招募 |
|
Mary Crowley Cancer Research Centers McCrc Headquarters Dallas, Texas 75251 |
活跃，非招募 |
|
Inova Schar Cancer Institute Falls Church, Virginia 22042 |
活跃，非招募 |
| 意大利 | |
|
Fondazione Del Piemonte Per L Oncologia Ircc Candiolo Candiolo 10060 |
活跃，非招募 |
|
Irccs Istituto Clinico Humanitas Rozzano 20089 |
活跃，非招募 |
|
Centro Ricerche Cliniche Di Verona (Crc) Verona 37124 |
活跃，非招募 |
| 西班牙 | |
|
Hospital Hm Nou Delfos Barcelona 08023 |
活跃，非招募 |
|
Hospital General Universitario Vall D Hebron 巴塞罗那 08035 |
活跃，非招募 |
|
Hospital Universitario Quironsalud Madrid Pozuelo de Alarcon 28223 |
活跃，非招募 |
|
Hospital Universitario Virgen Macarena Sevilla 41009 |
活跃，非招募 |
| 英国 | |
|
Guys Hospital 伦敦 SE1 9RT |
活跃，非招募 |
|
Hammersmith Hospital London W12 0HS |
活跃，非招募 |
纳入标准
纳入标准
* KRASG12C-mutated solid malignancy determined by a sponsor-approved assay using either tumor tissue or ctDNA.
* Histologically confirmed malignant solid tumor with locally advanced and/or metastatic disease.
* Only participants with NSCLC will be enrolled into Part 2 Cohort A.
* Only participants with CRC will be enrolled into Part 2 Cohort B.
* Part 1: Disease progression on or after at least 1 prior systemic treatment.
* Part 2 (Cohort A - NSCLC): Received an anti-PD-(L)1-containing regimen and platinum based chemotherapy regimen either concurrently or sequentially
* Part 2 (Cohort B - CRC): Received at least 1 line of systemic therapy that includes the combination of fluoropyrimidine-based chemotherapy (in combination with oxaliplatin and/or irinotecan) and either a vascular endothelial growth factor-targeting monoclonal antibody or an anti-epidermal growth factor receptor monoclonal antibody (if RAS wild type). Participants with MSI-H/dMMR CRC must also have received a prior immune checkpoint inhibitor approved for this indication.
* Measurable disease according to RECIST v1.1.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* 预计寿命 > 3 个月。
* Willingness to avoid pregnancy.
排除标准
排除标准：
* 已知的其他恶性肿瘤正在发展或需要积极治疗。
* 需要治疗的中枢神经系统（CNS）转移和/或脑膜疾病。
* Part 2 only: Prior treatment with an approved or investigational agent targeting KRASG12C.
* Toxicity from prior therapy that has not recovered to protocol-defined limits.
* Received thoracic radiation of > 30 Gy within 6 months of the first dose of study treatment.
* Participation in another interventional clinical study.
* History or evidence of interstitial lung disease, including noninfectious pneumonitis.
* Presence of gastrointestinal condition that may affect drug absorption.
* Active autoimmune disease requiring systemic treatment, including corticosteroids exceeding a daily dose of 10 mg of prednisone or equivalent.
* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy exceeding a daily dose of 10 mg of prednisone or equivalent.
* 需要系统治疗的活动性感染。
* 器官移植史，包括异体干细胞移植。
* Receipt of systemic antibiotics within 28 days of the first dose of study treatment.
* 在筛选期间和整个研究治疗期间，禁止使用益生菌。
* 在计划开始服用研究药物的 28 天内接种过活疫苗。
* 实验室数值超出《规程》规定的范围。
可能还需符合其他方案规定的纳入/排除标准。
