Trial Radar AI | ||
|---|---|---|
De klinische studie NCT06607185 voor Pancreas Ductaal Adenocarcinoom, Niet-kleincellige longkanker, Colorectale kanker, Gevorderde vaste tumor, Gemetastaseerde Solide Tumor is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Terug naar zoekresultaten
Eli LillyA Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
Informatie over klinische studies is voornamelijk in het Engels beschikbaar. Trial Radar AI kan echter helpen! Klik op 'Leg studie uit' om de informatie over de studie te bekijken en te bespreken in de taal van uw keuze.
De klinische studie NCT06607185 onderzoekt behandeling bij Pancreas Ductaal Adenocarcinoom, Niet-kleincellige longkanker, Colorectale kanker, Gevorderde vaste tumor, Gemetastaseerde Solide Tumor. Deze Fase 1 interventioneel-studie heeft de status recruterend. Het doel is om 750 deelnemers te includeren vanaf 21 oktober 2024. De studie wordt geleid door Eli Lilly en de voltooiing is gepland op 1 januari 2030. Laatste update op ClinicalTrials.gov: 5 november 2025.
Beknopte samenvatting
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.
Officiële titel
A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
Aandoeningen
Pancreas Ductaal AdenocarcinoomNiet-kleincellige longkankerColorectale kankerGevorderde vaste tumorGemetastaseerde Solide TumorAndere studie-ID's
- 27237
- J5Q-OX-JRDA (Overige identificatiecode) (Eli Lilly and Company)
NCT-ID
Startdatum (Werkelijk)
2024-10-21
Laatste update geplaatst
2025-11-05
Verwachte einddatum
2030-01
Inschrijving (Geschat)
750
Studietype
Interventioneel
FASE
Fase 1
Status
Recruterend
Trefwoorden
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
Primaire doel
Behandeling
Toewijzing
Niet-gerandomiseerd
Interventiemodel
Sequentieel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelLY4066434 Monotherapy Dose Escalation Escalating doses of LY4066434 administered orally. | LY4066434. Administered orally. |
ExperimenteelLY4066434 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. Carboplatine Administered intravenously. Cisplatin Administered intravenously. Pemetrexed Administered intravenously. Pembrolizumab Administered intravenously. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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
Centraal Contactpersoon
Contact: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, [email protected]
Contact: Physicians interested in becoming principal investigators please contact, [email protected]
56 Studielocaties in 9 landen
Universite Libre de Bruxelles (ULB) - Institut Jules Bordet, Brussels, 1070, Belgium
Recruterend
Cliniques universitaires Saint-Luc, Brussels, 1200, Belgium
Recruterend
UZ Gent, Ghent, 9000, Belgium
Recruterend
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
Recruterend
Arizona
Mayo Clinic, Phoenix, Arizona, 85054, United States
Recruterend
California
City of Hope, Duarte, California, 91010, United States
Recruterend
University of California, Los Angeles (UCLA), Los Angeles, California, 90025, United States
Recruterend
Colorado
University of Colorado Denver, Denver, Colorado, 80220, United States
Nog niet rekruterend
Connecticut
Yale University School of Medicine - Yale Cancer Center, New Haven, Connecticut, 06520-8028, United States
Recruterend
Illinois
The University of Chicago Medical Center (UCMC), Chicago, Illinois, 60637, United States
Recruterend
Indiana
Indiana University (IU), Indianapolis, Indiana, 46202, United States
Recruterend
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Recruterend
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Recruterend
Michigan
Henry Ford Health System, Detroit, Michigan, 48202, United States
Recruterend
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan, 49546, United States
Recruterend
Minnesota
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
Nog niet rekruterend
New York
Columbia University, New York, New York, 10032, United States
Recruterend
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Recruterend
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
Recruterend
Ohio
Cleveland Clinic, Cleveland, Ohio, 44195, United States
Recruterend
Oklahoma
University of Oklahoma - Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States
Nog niet rekruterend
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States
Recruterend
Tennessee
Sarah Cannon Research Institute/SCRI, Nashville, Tennessee, 37203, United States
Recruterend
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
Recruterend
Texas
University of Texas Southwestern, Dallas, Texas, 75244, United States
Recruterend
MD Anderson Cancer Center, Houston, Texas, 77030, United States
Recruterend
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, 78229, United States
Recruterend
Virginia
Virginia Cancer Specialists, Fairfax, Virginia, 22031, United States
Recruterend
Washington
Swedish Cancer Institute (SCI), Seattle, Washington, 98104, United States
Recruterend
Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing, 100021, China
Nog niet rekruterend
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, 310006, China
Nog niet rekruterend
Shandong Province Tumor Hospital, Jinan, 250117, China
Nog niet rekruterend
Shanghai East Hospital, Tongji University, Shanghai, 0200120, China
Nog niet rekruterend
Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China
Nog niet rekruterend
Centre Leon Berard, Lyon, 69008, France
Nog niet rekruterend
Institut Gustave Roussy, Villejuif, 94805, France
Nog niet rekruterend
Charite Universitaetsmedizin Berlin, Berlin, 10117, Germany
Nog niet rekruterend
Krankenhaus Nordwest GmbH, Frankfurt, 60488, Germany
Recruterend
Asklepios Kliniken Hamburg GmbH - Asklepios Klinik Altona, Hamburg, 22763, Germany
Recruterend
SLK-Kliniken Heilbronn GmBH, Heilbronn, 74078, Germany
Recruterend
Universitaetsklinikum Wuerzburg, Würzburg, 97080, Germany
Recruterend
Centro Ricerche Cliniche di Verona s.r.l., Verona, 37134, Italy
Recruterend
National Cancer Center Hospital East, Chiba, 277-8577, Japan
Recruterend
Kyoto University Hospital, Kyoto, 606-8507, Japan
Recruterend
Shizuoka Cancer Center, Shizuoka, 411-8777, Japan
Recruterend
National Cancer Center Hospital, Tokyo, 104-0045, Japan
Recruterend
Cancer Institute Hospital of JFCR, Tokyo, 135-8550, Japan
Recruterend
Hospital del Mar, Barcelona, 08003, Spain
Recruterend
Hospital Universitario Vall d'Hebron, Barcelona, 08035, Spain
Recruterend
Institut Catala d'Oncologia - L'Hospitalet, Barcelona, 08908, Spain
Recruterend
Hospital General Universitario Gregorio Maranon, Madrid, 28007, Spain
Recruterend
Hospital Universitario Ramon y Cajal, Madrid, 28034, Spain
Recruterend
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
Recruterend
Hospital Regional Universitario de Malaga, Málaga, 29010, Spain
Recruterend
National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, 300195, Taiwan
Recruterend
National Taiwan University Hospital, Taipei, 10016, Taiwan
Recruterend