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Eli LillyA Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06607185 untersucht Behandlung im Zusammenhang mit Duktales Adenokarzinom der Bauchspeicheldrüse, Nicht-kleinzelliger Lungenkrebs, Kolorektalkrebs, Fortgeschrittener solider Tumor, Metastatischer Solider Tumor. Diese interventionsstudie der Phase 1 hat den Status offene rekrutierung und startete am 21. Oktober 2024. Es ist geplant, 750 Teilnehmer aufzunehmen. Durchgeführt von Eli Lilly wird der Abschluss für 1. Januar 2030 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 5. November 2025 aktualisiert.
Kurzbeschreibung
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.
Offizieller Titel
A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
Erkrankungen
Duktales Adenokarzinom der BauchspeicheldrüseNicht-kleinzelliger LungenkrebsKolorektalkrebsFortgeschrittener solider TumorMetastatischer Solider TumorWeitere Studien-IDs
- 27237
- J5Q-OX-JRDA (Andere Kennung) (Eli Lilly and Company)
NCT-Nummer
Studienbeginn (tatsächlich)
2024-10-21
Zuletzt aktualisiert
2025-11-05
Studienende (vorauss.)
2030-01
Geplante Rekrutierung
750
Studientyp
Interventionsstudie
PHASE
Phase 1
Status
Offene Rekrutierung
Stichwörter
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
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht randomisiert
Interventionsmodell
Sequentiell
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellLY4066434 Monotherapy Dose Escalation Escalating doses of LY4066434 administered orally. | LY4066434. Administered orally. |
ExperimentellLY4066434 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. Carboplatin Administered intravenously. Cisplatin Administered intravenously. Pemetrexed Administered intravenously. Pembrolizumab Administered intravenously. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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
Zentrale Studienkontakte
Kontakt: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, [email protected]
Kontakt: Physicians interested in becoming principal investigators please contact, [email protected]
56 Studienstandorte in 9 Ländern
Charite Universitaetsmedizin Berlin, Berlin, 10117, Germany
Noch nicht rekrutierend
Krankenhaus Nordwest GmbH, Frankfurt, 60488, Germany
Offene Rekrutierung
Asklepios Kliniken Hamburg GmbH - Asklepios Klinik Altona, Hamburg, 22763, Germany
Offene Rekrutierung
SLK-Kliniken Heilbronn GmBH, Heilbronn, 74078, Germany
Offene Rekrutierung
Universitaetsklinikum Wuerzburg, Würzburg, 97080, Germany
Offene Rekrutierung
Universite Libre de Bruxelles (ULB) - Institut Jules Bordet, Brussels, 1070, Belgium
Offene Rekrutierung
Cliniques universitaires Saint-Luc, Brussels, 1200, Belgium
Offene Rekrutierung
UZ Gent, Ghent, 9000, Belgium
Offene Rekrutierung
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
Offene Rekrutierung
Arizona
Mayo Clinic, Phoenix, Arizona, 85054, United States
Offene Rekrutierung
California
City of Hope, Duarte, California, 91010, United States
Offene Rekrutierung
University of California, Los Angeles (UCLA), Los Angeles, California, 90025, United States
Offene Rekrutierung
Colorado
University of Colorado Denver, Denver, Colorado, 80220, United States
Noch nicht rekrutierend
Connecticut
Yale University School of Medicine - Yale Cancer Center, New Haven, Connecticut, 06520-8028, United States
Offene Rekrutierung
Illinois
The University of Chicago Medical Center (UCMC), Chicago, Illinois, 60637, United States
Offene Rekrutierung
Indiana
Indiana University (IU), Indianapolis, Indiana, 46202, United States
Offene Rekrutierung
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Offene Rekrutierung
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Offene Rekrutierung
Michigan
Henry Ford Health System, Detroit, Michigan, 48202, United States
Offene Rekrutierung
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan, 49546, United States
Offene Rekrutierung
Minnesota
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
Noch nicht rekrutierend
New York
Columbia University, New York, New York, 10032, United States
Offene Rekrutierung
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Offene Rekrutierung
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
Offene Rekrutierung
Ohio
Cleveland Clinic, Cleveland, Ohio, 44195, United States
Offene Rekrutierung
Oklahoma
University of Oklahoma - Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States
Noch nicht rekrutierend
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States
Offene Rekrutierung
Tennessee
Sarah Cannon Research Institute/SCRI, Nashville, Tennessee, 37203, United States
Offene Rekrutierung
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
Offene Rekrutierung
Texas
University of Texas Southwestern, Dallas, Texas, 75244, United States
Offene Rekrutierung
MD Anderson Cancer Center, Houston, Texas, 77030, United States
Offene Rekrutierung
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, 78229, United States
Offene Rekrutierung
Virginia
Virginia Cancer Specialists, Fairfax, Virginia, 22031, United States
Offene Rekrutierung
Washington
Swedish Cancer Institute (SCI), Seattle, Washington, 98104, United States
Offene Rekrutierung
Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing, 100021, China
Noch nicht rekrutierend
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, 310006, China
Noch nicht rekrutierend
Shandong Province Tumor Hospital, Jinan, 250117, China
Noch nicht rekrutierend
Shanghai East Hospital, Tongji University, Shanghai, 0200120, China
Noch nicht rekrutierend
Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China
Noch nicht rekrutierend
Centre Leon Berard, Lyon, 69008, France
Noch nicht rekrutierend
Institut Gustave Roussy, Villejuif, 94805, France
Noch nicht rekrutierend
Centro Ricerche Cliniche di Verona s.r.l., Verona, 37134, Italy
Offene Rekrutierung
National Cancer Center Hospital East, Chiba, 277-8577, Japan
Offene Rekrutierung
Kyoto University Hospital, Kyoto, 606-8507, Japan
Offene Rekrutierung
Shizuoka Cancer Center, Shizuoka, 411-8777, Japan
Offene Rekrutierung
National Cancer Center Hospital, Tokyo, 104-0045, Japan
Offene Rekrutierung
Cancer Institute Hospital of JFCR, Tokyo, 135-8550, Japan
Offene Rekrutierung
Hospital del Mar, Barcelona, 08003, Spain
Offene Rekrutierung
Hospital Universitario Vall d'Hebron, Barcelona, 08035, Spain
Offene Rekrutierung
Institut Catala d'Oncologia - L'Hospitalet, Barcelona, 08908, Spain
Offene Rekrutierung
Hospital General Universitario Gregorio Maranon, Madrid, 28007, Spain
Offene Rekrutierung
Hospital Universitario Ramon y Cajal, Madrid, 28034, Spain
Offene Rekrutierung
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
Offene Rekrutierung
Hospital Regional Universitario de Malaga, Málaga, 29010, Spain
Offene Rekrutierung
National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, 300195, Taiwan
Offene Rekrutierung
National Taiwan University Hospital, Taipei, 10016, Taiwan
Offene Rekrutierung