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治験 NCT06607185（対象：膵管腺癌、非小細胞肺癌、大腸がん、進行固形腫瘍、転移性固形腫瘍）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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イーライリリーA Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06607185 は 膵管腺癌、非小細胞肺癌、大腸がん、進行固形腫瘍、転移性固形腫瘍 に関する 治療 の研究で、第I相・第一段階 介入研究 臨床試験 です。現在は 募集中 で、2024年10月21日 から開始しています。750 名の参加者 の募集が計画されています。この治験は イーライリリー によって主催され、2030年1月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年11月5日 です。
概要
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.
公式タイトル
A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
疾患／病気
膵管腺癌非小細胞肺癌大腸がん進行固形腫瘍転移性固形腫瘍その他の研究識別子
- 27237
- J5Q-OX-JRDA (その他の識別子) (Eli Lilly and Company)
NCT番号
開始日
2024-10-21
最終更新日
2025-11-05
終了予定日
2030-01
目標参加者数
750
試験の種類
介入研究
治験の相・段階
第I相・第一段階
状況
募集中
キーワード
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
主目的
治療
割付方法
非無作為化
介入モデル
逐次割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的LY4066434 Monotherapy Dose Escalation Escalating doses of LY4066434 administered orally. | LY4066434. Administered orally. |
実験的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. カルボプラチン Administered intravenously. Cisplatin Administered intravenously. Pemetrexed Administered intravenously. Pembrolizumab Administered intravenously. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- 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
イーライリリー357 件のアクティブな治験を探索試験中央連絡先
連絡先: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, [email protected]
連絡先: Physicians interested in becoming principal investigators please contact, [email protected]
56 9カ国の場所
National Cancer Center Hospital East, Chiba, 277-8577, Japan
募集中
Kyoto University Hospital, Kyoto, 606-8507, Japan
募集中
Shizuoka Cancer Center, Shizuoka, 411-8777, Japan
募集中
National Cancer Center Hospital, Tokyo, 104-0045, Japan
募集中
Cancer Institute Hospital of JFCR, Tokyo, 135-8550, Japan
募集中
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
募集中
Arizona
Mayo Clinic, Phoenix, Arizona, 85054, United States
募集中
California
City of Hope, Duarte, California, 91010, United States
募集中
University of California, Los Angeles (UCLA), Los Angeles, California, 90025, United States
募集中
Colorado
University of Colorado Denver, Denver, Colorado, 80220, United States
募集未定
Connecticut
Yale University School of Medicine - Yale Cancer Center, New Haven, Connecticut, 06520-8028, United States
募集中
Illinois
The University of Chicago Medical Center (UCMC), Chicago, Illinois, 60637, United States
募集中
Indiana
Indiana University (IU), Indianapolis, Indiana, 46202, United States
募集中
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
募集中
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
募集中
Michigan
Henry Ford Health System, Detroit, Michigan, 48202, United States
募集中
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan, 49546, United States
募集中
Minnesota
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
募集未定
New York
Columbia University, New York, New York, 10032, United States
募集中
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
募集中
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
募集中
Ohio
Cleveland Clinic, Cleveland, Ohio, 44195, United States
募集中
Oklahoma
University of Oklahoma - Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States
募集未定
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States
募集中
Tennessee
Sarah Cannon Research Institute/SCRI, Nashville, Tennessee, 37203, United States
募集中
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
募集中
Texas
University of Texas Southwestern, Dallas, Texas, 75244, United States
募集中
MD Anderson Cancer Center, Houston, Texas, 77030, United States
募集中
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, 78229, United States
募集中
Virginia
Virginia Cancer Specialists, Fairfax, Virginia, 22031, United States
募集中
Washington
Swedish Cancer Institute (SCI), Seattle, Washington, 98104, United States
募集中
Universite Libre de Bruxelles (ULB) - Institut Jules Bordet, Brussels, 1070, Belgium
募集中
Cliniques universitaires Saint-Luc, Brussels, 1200, Belgium
募集中
UZ Gent, Ghent, 9000, Belgium
募集中
Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing, 100021, China
募集未定
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, 310006, China
募集未定
Shandong Province Tumor Hospital, Jinan, 250117, China
募集未定
Shanghai East Hospital, Tongji University, Shanghai, 0200120, China
募集未定
Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China
募集未定
Centre Leon Berard, Lyon, 69008, France
募集未定
Institut Gustave Roussy, Villejuif, 94805, France
募集未定
Charite Universitaetsmedizin Berlin, Berlin, 10117, Germany
募集未定
Krankenhaus Nordwest GmbH, Frankfurt, 60488, Germany
募集中
Asklepios Kliniken Hamburg GmbH - Asklepios Klinik Altona, Hamburg, 22763, Germany
募集中
SLK-Kliniken Heilbronn GmBH, Heilbronn, 74078, Germany
募集中
Universitaetsklinikum Wuerzburg, Würzburg, 97080, Germany
募集中
Centro Ricerche Cliniche di Verona s.r.l., Verona, 37134, Italy
募集中
Hospital del Mar, Barcelona, 08003, Spain
募集中
Hospital Universitario Vall d'Hebron, Barcelona, 08035, Spain
募集中
Institut Catala d'Oncologia - L'Hospitalet, Barcelona, 08908, Spain
募集中
Hospital General Universitario Gregorio Maranon, Madrid, 28007, Spain
募集中
Hospital Universitario Ramon y Cajal, Madrid, 28034, Spain
募集中
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
募集中
Hospital Regional Universitario de Malaga, Málaga, 29010, Spain
募集中
National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, 300195, Taiwan
募集中
National Taiwan University Hospital, Taipei, 10016, Taiwan
募集中