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临床试验 NCT06607185 针对胰腺导管腺癌，非小细胞肺癌，结直肠癌，晚期实体肿瘤，转移性实体瘤目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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礼来A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“解释临床试验”即可查看和讨论您选择的语言的试验信息。
临床试验NCT06607185旨在研究治疗，主要针对胰腺导管腺癌，非小细胞肺癌，结直肠癌，晚期实体肿瘤，转移性实体瘤。这是一项I期 (第一期) 干预性研究试验，目前试验状态为招募中。试验始于2024年10月21日，计划招募750名患者。该研究由礼来主导，预计于2030年1月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年11月5日。
简要概括
The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.
官方标题
A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
疾病
胰腺导管腺癌非小细胞肺癌结直肠癌晚期实体肿瘤转移性实体瘤其他研究标识符
- 27237
- J5Q-OX-JRDA (其他标识符) (Eli Lilly and Company)
NCT编号
实际开始日期
2024-10-21
最近更新发布
2025-11-05
预计完成日期
2030-01
计划入组人数
750
研究类型
干预性研究
试验分期 (阶段)
I期 (第一期)
试验状态
招募中
关键词
KRAS
KRAS mutation
KRASG12C
KRASG12D
KRASG12V
KRASG12S
KRASG12A
KRASG13D
LY4066434
Targeted therapy
Lung cancer
Pancreas cancer
Colon cancer
Rectal cancer
Colorectal cancer
Ovarian cancer
Endometrial cancer
Cholangiocarcinoma
Esophageal cancer
KRAS-mutant tumor
PanKRAS
Pan KRAS
KRAS mutation
KRASG12C
KRASG12D
KRASG12V
KRASG12S
KRASG12A
KRASG13D
LY4066434
Targeted therapy
Lung cancer
Pancreas cancer
Colon cancer
Rectal cancer
Colorectal cancer
Ovarian cancer
Endometrial cancer
Cholangiocarcinoma
Esophageal cancer
KRAS-mutant tumor
PanKRAS
Pan KRAS
主要目的
治疗方法
分配方式
非随机
干预模型
序贯设计
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性LY4066434 Monotherapy Dose Escalation Escalating doses of LY4066434 administered orally. | LY4066434. Administered orally. |
实验性LY4066434 Dose Optimization LY4066434 administered orally either alone or with another investigational agent. | LY4066434. Administered orally. Cetuximab Administered intravenously. Nab Paclitaxel Administered intravenously. Gemcitabine Administered intravenously. Oxaliplatin Administered intravenously. Leucovorin Administered intravenously. Irinotecan Administered intravenously. 5Fluorouracil Administered intravenously. 卡铂 Administered intravenously. Cisplatin Administered intravenously. Pemetrexed Administered intravenously. Pembrolizumab Administered intravenously. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Number of Participants with Dose-limiting Toxicities (DLTs) | During the first cycle of LY4066434 treatment (up to 28 days) | |
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Up to approximately 5 years |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Overall Response Rate (ORR) | ORR as assessed by investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) | Up to approximately 5 years |
Best Overall Response (BOR) | BOR as assessed by investigator per RECIST v1.1 | Up to approximately 5 years |
Duration of Response (DOR) | DOR as assessed by investigator per RECIST v1.1 | Up to approximately 5 years |
Disease Control Rate (DCR) | DCR as assessed by investigator per RECIST v1.1 | Up to approximately 5 years |
Time to Response (TTR) | TTR as assessed by investigator per RECIST v1.1 | Up to approximately 5 years |
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4066434 Alone | PK: Cmax of LY4066434 | Predose through Day 168 |
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4066434 in Combination With Other Agents | PK: Cmax of LY4066434 | Predose through Day 168 |
PK: Time to Maximum Concentration (Tmax) of LY4066434 Alone | PK: Tmax of LY4066434 | Predose through Day 168 |
PK: Time to Maximum Concentration (Tmax) of LY4066434 in Combination With Other Agents | PK: Tmax of LY4066434 | Predose through Day 168 |
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4066434 Alone | PK: AUC of LY4066434 | Predose through Day 168 |
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4066434 in Combination With Other Agents | PK: AUC of LY4066434 | Predose through Day 168 |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor DNA
- Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer
- Have measurable disease per RECIST 1.1
- Have an ECOG performance status of ≤1
- Must not be pregnant and/or planning to breastfeed during the trial or within 180 days of the last dose of trial intervention
- Must be able to swallow tablets
- Participants with asymptomatic or treated CNS disease may be eligible
- Have known active CNS metastases and/or carcinomatous meningitis
- Have any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 1 at the time of starting trial treatment, except for alopecia, hearing loss, peripheral neuropathy and ongoing endocrinopathies controlled on appropriate replacement therapy
- Have significant cardiovascular disease defined as unstable angina or acute coronary syndrome, history of myocardial infarction, known left ventricular ejection fraction or heart failure, uncontrolled or symptomatic arrhythmias.
- Have known active hepatitis B virus (HBV), hepatitis C virus (HCV) or untreated HIV infection
- Have other active malignancy unless in remission with life expectancy greater than 2 years.
- Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Have history of non-infectious pneumonitis/interstitial lung disease that received steroids or has current clinically significant pneumonitis/interstitial lung disease
研究中心联系人
联系人: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, [email protected]
联系人: Physicians interested in becoming principal investigators please contact, [email protected]
56 位于 9 个国家/地区的研究中心
Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing, 100021, China
尚未招募
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, 310006, China
尚未招募
Shandong Province Tumor Hospital, Jinan, 250117, China
尚未招募
Shanghai East Hospital, Tongji University, Shanghai, 0200120, China
尚未招募
Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China
尚未招募
National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, 300195, Taiwan
招募中
National Taiwan University Hospital, Taipei, 10016, Taiwan
招募中
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
招募中
Arizona
Mayo Clinic, Phoenix, Arizona, 85054, United States
招募中
California
City of Hope, Duarte, California, 91010, United States
招募中
University of California, Los Angeles (UCLA), Los Angeles, California, 90025, United States
招募中
Colorado
University of Colorado Denver, Denver, Colorado, 80220, United States
尚未招募
Connecticut
Yale University School of Medicine - Yale Cancer Center, New Haven, Connecticut, 06520-8028, United States
招募中
Illinois
The University of Chicago Medical Center (UCMC), Chicago, Illinois, 60637, United States
招募中
Indiana
Indiana University (IU), Indianapolis, Indiana, 46202, United States
招募中
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
招募中
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
招募中
Michigan
Henry Ford Health System, Detroit, Michigan, 48202, United States
招募中
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan, 49546, United States
招募中
Minnesota
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
尚未招募
New York
Columbia University, New York, New York, 10032, United States
招募中
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
招募中
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
招募中
Ohio
Cleveland Clinic, Cleveland, Ohio, 44195, United States
招募中
Oklahoma
University of Oklahoma - Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States
尚未招募
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States
招募中
Tennessee
Sarah Cannon Research Institute/SCRI, Nashville, Tennessee, 37203, United States
招募中
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
招募中
Texas
University of Texas Southwestern, Dallas, Texas, 75244, United States
招募中
MD Anderson Cancer Center, Houston, Texas, 77030, United States
招募中
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, 78229, United States
招募中
Virginia
Virginia Cancer Specialists, Fairfax, Virginia, 22031, United States
招募中
Washington
Swedish Cancer Institute (SCI), Seattle, Washington, 98104, United States
招募中
Universite Libre de Bruxelles (ULB) - Institut Jules Bordet, Brussels, 1070, Belgium
招募中
Cliniques universitaires Saint-Luc, Brussels, 1200, Belgium
招募中
UZ Gent, Ghent, 9000, Belgium
招募中
Centre Leon Berard, Lyon, 69008, France
尚未招募
Institut Gustave Roussy, Villejuif, 94805, France
尚未招募
Charite Universitaetsmedizin Berlin, Berlin, 10117, Germany
尚未招募
Krankenhaus Nordwest GmbH, Frankfurt, 60488, Germany
招募中
Asklepios Kliniken Hamburg GmbH - Asklepios Klinik Altona, Hamburg, 22763, Germany
招募中
SLK-Kliniken Heilbronn GmBH, Heilbronn, 74078, Germany
招募中
Universitaetsklinikum Wuerzburg, Würzburg, 97080, Germany
招募中
Centro Ricerche Cliniche di Verona s.r.l., Verona, 37134, Italy
招募中
National Cancer Center Hospital East, Chiba, 277-8577, Japan
招募中
Kyoto University Hospital, Kyoto, 606-8507, Japan
招募中
Shizuoka Cancer Center, Shizuoka, 411-8777, Japan
招募中
National Cancer Center Hospital, Tokyo, 104-0045, Japan
招募中
Cancer Institute Hospital of JFCR, Tokyo, 135-8550, Japan
招募中
Hospital del Mar, Barcelona, 08003, Spain
招募中
Hospital Universitario Vall d'Hebron, Barcelona, 08035, Spain
招募中
Institut Catala d'Oncologia - L'Hospitalet, Barcelona, 08908, Spain
招募中
Hospital General Universitario Gregorio Maranon, Madrid, 28007, Spain
招募中
Hospital Universitario Ramon y Cajal, Madrid, 28034, Spain
招募中
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
招募中
Hospital Regional Universitario de Malaga, Málaga, 29010, Spain
招募中