ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT06607185 के लिए अग्न्याशयी डक्टल एडेनोकार्सिनोमा, गैर-छोटी कोशिका फेफड़े का कैंसर, कोलो-रेक्टल कैंसर, उन्नत ठोस ट्यूमर, मेटास्टेटिक ठोस ट्यूमर वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
खोज पर वापस जाएँ
एली लिलीA Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT06607185 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन अग्न्याशयी डक्टल एडेनोकार्सिनोमा, गैर-छोटी कोशिका फेफड़े का कैंसर, कोलो-रेक्टल कैंसर, उन्नत ठोस ट्यूमर, मेटास्टेटिक ठोस ट्यूमर से जुड़ा हुआ है और यह एक चरण I हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 21 अक्तूबर 2024 को हुई थी, और इसमें कुल 750 प्रतिभागियों के नामांकन की योजना है। एली लिली इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 जनवरी 2030 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 5 नवंबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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.
आधिकारिक शीर्षक
A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
चिकित्सीय स्थितियाँ
अग्न्याशयी डक्टल एडेनोकार्सिनोमागैर-छोटी कोशिका फेफड़े का कैंसरकोलो-रेक्टल कैंसरउन्नत ठोस ट्यूमरमेटास्टेटिक ठोस ट्यूमरअन्य अध्ययन आईडी
- 27237
- J5Q-OX-JRDA (अन्य पहचानकर्ता) (Eli Lilly and Company)
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2024-10-21
अंतिम अद्यतन प्रकाशित
2025-11-05
अध्ययन की समाप्ति तिथि (अनुमानित)
2030-01
नामांकन (अनुमानित)
750
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण I
स्थिति
भर्ती जारी
प्रमुख शब्द
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
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
गैर-यादृच्छिक
हस्तक्षेप मॉडल
अनुक्रमिक
अंधकरण
कोई नहीं (खुलें लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/हाथ | हस्तक्षेप/इलाज |
|---|---|
प्रयोगात्मकLY4066434 Monotherapy Dose Escalation Escalating doses of LY4066434 administered orally. | LY4066434. Administered orally. |
प्रयोगात्मकLY4066434 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. कार्बोप्लाटिन Administered intravenously. Cisplatin Administered intravenously. Pemetrexed Administered intravenously. Pembrolizumab Administered intravenously. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
- 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
अध्ययन केंद्रीय संपर्क
संपर्क: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, [email protected]
संपर्क: Physicians interested in becoming principal investigators please contact, [email protected]
56 9 देशों में अध्ययन स्थल
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
भर्ती जारी
Arizona
Mayo Clinic, Phoenix, Arizona, 85054, United States
भर्ती जारी
California
City of Hope, Duarte, California, 91010, United States
भर्ती जारी
University of California, Los Angeles (UCLA), Los Angeles, California, 90025, United States
भर्ती जारी
Colorado
University of Colorado Denver, Denver, Colorado, 80220, United States
अभी भर्ती शुरू नहीं
Connecticut
Yale University School of Medicine - Yale Cancer Center, New Haven, Connecticut, 06520-8028, United States
भर्ती जारी
Illinois
The University of Chicago Medical Center (UCMC), Chicago, Illinois, 60637, United States
भर्ती जारी
Indiana
Indiana University (IU), Indianapolis, Indiana, 46202, United States
भर्ती जारी
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
भर्ती जारी
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
भर्ती जारी
Michigan
Henry Ford Health System, Detroit, Michigan, 48202, United States
भर्ती जारी
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan, 49546, United States
भर्ती जारी
Minnesota
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
अभी भर्ती शुरू नहीं
New York
Columbia University, New York, New York, 10032, United States
भर्ती जारी
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
भर्ती जारी
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
भर्ती जारी
Ohio
Cleveland Clinic, Cleveland, Ohio, 44195, United States
भर्ती जारी
Oklahoma
University of Oklahoma - Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States
अभी भर्ती शुरू नहीं
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States
भर्ती जारी
Tennessee
Sarah Cannon Research Institute/SCRI, Nashville, Tennessee, 37203, United States
भर्ती जारी
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
भर्ती जारी
Texas
University of Texas Southwestern, Dallas, Texas, 75244, United States
भर्ती जारी
MD Anderson Cancer Center, Houston, Texas, 77030, United States
भर्ती जारी
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, 78229, United States
भर्ती जारी
Virginia
Virginia Cancer Specialists, Fairfax, Virginia, 22031, United States
भर्ती जारी
Washington
Swedish Cancer Institute (SCI), Seattle, Washington, 98104, United States
भर्ती जारी
Universite Libre de Bruxelles (ULB) - Institut Jules Bordet, Brussels, 1070, Belgium
भर्ती जारी
Cliniques universitaires Saint-Luc, Brussels, 1200, Belgium
भर्ती जारी
UZ Gent, Ghent, 9000, Belgium
भर्ती जारी
Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing, 100021, China
अभी भर्ती शुरू नहीं
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, 310006, China
अभी भर्ती शुरू नहीं
Shandong Province Tumor Hospital, Jinan, 250117, China
अभी भर्ती शुरू नहीं
Shanghai East Hospital, Tongji University, Shanghai, 0200120, China
अभी भर्ती शुरू नहीं
Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China
अभी भर्ती शुरू नहीं
Centre Leon Berard, Lyon, 69008, France
अभी भर्ती शुरू नहीं
Institut Gustave Roussy, Villejuif, 94805, France
अभी भर्ती शुरू नहीं
Charite Universitaetsmedizin Berlin, Berlin, 10117, Germany
अभी भर्ती शुरू नहीं
Krankenhaus Nordwest GmbH, Frankfurt, 60488, Germany
भर्ती जारी
Asklepios Kliniken Hamburg GmbH - Asklepios Klinik Altona, Hamburg, 22763, Germany
भर्ती जारी
SLK-Kliniken Heilbronn GmBH, Heilbronn, 74078, Germany
भर्ती जारी
Universitaetsklinikum Wuerzburg, Würzburg, 97080, Germany
भर्ती जारी
Centro Ricerche Cliniche di Verona s.r.l., Verona, 37134, Italy
भर्ती जारी
National Cancer Center Hospital East, Chiba, 277-8577, Japan
भर्ती जारी
Kyoto University Hospital, Kyoto, 606-8507, Japan
भर्ती जारी
Shizuoka Cancer Center, Shizuoka, 411-8777, Japan
भर्ती जारी
National Cancer Center Hospital, Tokyo, 104-0045, Japan
भर्ती जारी
Cancer Institute Hospital of JFCR, Tokyo, 135-8550, Japan
भर्ती जारी
Hospital del Mar, Barcelona, 08003, Spain
भर्ती जारी
Hospital Universitario Vall d'Hebron, Barcelona, 08035, Spain
भर्ती जारी
Institut Catala d'Oncologia - L'Hospitalet, Barcelona, 08908, Spain
भर्ती जारी
Hospital General Universitario Gregorio Maranon, Madrid, 28007, Spain
भर्ती जारी
Hospital Universitario Ramon y Cajal, Madrid, 28034, Spain
भर्ती जारी
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
भर्ती जारी
Hospital Regional Universitario de Malaga, Málaga, 29010, Spain
भर्ती जारी
National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, 300195, Taiwan
भर्ती जारी
National Taiwan University Hospital, Taipei, 10016, Taiwan
भर्ती जारी