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L'essai clinique NCT06607185 pour Adénocarcinome canalaire pancréatique, Cancer du poumon non à petites cellules, Cancer colo-rectal, Tumeur solide avancée, Tumeur solide métastatique est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Eli LillyA Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT06607185 est conçu pour étudier le treatment de Adénocarcinome canalaire pancréatique, Cancer du poumon non à petites cellules, Cancer colo-rectal, Tumeur solide avancée, Tumeur solide métastatique. Il s'agit d'un essai interventionnel en Phase I. Son statut actuel est : en recrutement. L'essai a débuté le 21 octobre 2024 et vise à recruter 750 participants. Dirigé par Eli Lilly, l'essai devrait être terminé d'ici le 1 janvier 2030. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 5 novembre 2025.
Résumé succinct
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.
Titre officiel
A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
Conditions
Adénocarcinome canalaire pancréatiqueCancer du poumon non à petites cellulesCancer colo-rectalTumeur solide avancéeTumeur solide métastatiqueAutres identifiants de l'essai
- 27237
- J5Q-OX-JRDA (Autre Identifiant) (Eli Lilly and Company)
Numéro NCT
Date de début (réel)
2024-10-21
Dernière mise à jour publiée
2025-11-05
Date de fin (estimée)
2030-01
Inscription (estimée)
750
Type d'essai
Interventionnel
PHASE
Phase I
Statut
En recrutement
Mots clés
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
Objectif principal
Traitement
Plan d'attribution
Non aléatoire
Modèle d'intervention
Séquentiel
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalLY4066434 Monotherapy Dose Escalation Escalating doses of LY4066434 administered orally. | LY4066434. Administered orally. |
ExpérimentalLY4066434 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. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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
Contact central de l'essai
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 Centres de l'essai dans 9 pays
Centre Leon Berard, Lyon, 69008, France
Pas encore en recrutement
Institut Gustave Roussy, Villejuif, 94805, France
Pas encore en recrutement
Universite Libre de Bruxelles (ULB) - Institut Jules Bordet, Brussels, 1070, Belgium
En recrutement
Cliniques universitaires Saint-Luc, Brussels, 1200, Belgium
En recrutement
UZ Gent, Ghent, 9000, Belgium
En recrutement
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
En recrutement
Arizona
Mayo Clinic, Phoenix, Arizona, 85054, United States
En recrutement
California
City of Hope, Duarte, California, 91010, United States
En recrutement
University of California, Los Angeles (UCLA), Los Angeles, California, 90025, United States
En recrutement
Colorado
University of Colorado Denver, Denver, Colorado, 80220, United States
Pas encore en recrutement
Connecticut
Yale University School of Medicine - Yale Cancer Center, New Haven, Connecticut, 06520-8028, United States
En recrutement
Illinois
The University of Chicago Medical Center (UCMC), Chicago, Illinois, 60637, United States
En recrutement
Indiana
Indiana University (IU), Indianapolis, Indiana, 46202, United States
En recrutement
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
En recrutement
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
En recrutement
Michigan
Henry Ford Health System, Detroit, Michigan, 48202, United States
En recrutement
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan, 49546, United States
En recrutement
Minnesota
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
Pas encore en recrutement
New York
Columbia University, New York, New York, 10032, United States
En recrutement
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
En recrutement
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
En recrutement
Ohio
Cleveland Clinic, Cleveland, Ohio, 44195, United States
En recrutement
Oklahoma
University of Oklahoma - Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States
Pas encore en recrutement
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States
En recrutement
Tennessee
Sarah Cannon Research Institute/SCRI, Nashville, Tennessee, 37203, United States
En recrutement
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
En recrutement
Texas
University of Texas Southwestern, Dallas, Texas, 75244, United States
En recrutement
MD Anderson Cancer Center, Houston, Texas, 77030, United States
En recrutement
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, 78229, United States
En recrutement
Virginia
Virginia Cancer Specialists, Fairfax, Virginia, 22031, United States
En recrutement
Washington
Swedish Cancer Institute (SCI), Seattle, Washington, 98104, United States
En recrutement
Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing, 100021, China
Pas encore en recrutement
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, 310006, China
Pas encore en recrutement
Shandong Province Tumor Hospital, Jinan, 250117, China
Pas encore en recrutement
Shanghai East Hospital, Tongji University, Shanghai, 0200120, China
Pas encore en recrutement
Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China
Pas encore en recrutement
Charite Universitaetsmedizin Berlin, Berlin, 10117, Germany
Pas encore en recrutement
Krankenhaus Nordwest GmbH, Frankfurt, 60488, Germany
En recrutement
Asklepios Kliniken Hamburg GmbH - Asklepios Klinik Altona, Hamburg, 22763, Germany
En recrutement
SLK-Kliniken Heilbronn GmBH, Heilbronn, 74078, Germany
En recrutement
Universitaetsklinikum Wuerzburg, Würzburg, 97080, Germany
En recrutement
Centro Ricerche Cliniche di Verona s.r.l., Verona, 37134, Italy
En recrutement
National Cancer Center Hospital East, Chiba, 277-8577, Japan
En recrutement
Kyoto University Hospital, Kyoto, 606-8507, Japan
En recrutement
Shizuoka Cancer Center, Shizuoka, 411-8777, Japan
En recrutement
National Cancer Center Hospital, Tokyo, 104-0045, Japan
En recrutement
Cancer Institute Hospital of JFCR, Tokyo, 135-8550, Japan
En recrutement
Hospital del Mar, Barcelona, 08003, Spain
En recrutement
Hospital Universitario Vall d'Hebron, Barcelona, 08035, Spain
En recrutement
Institut Catala d'Oncologia - L'Hospitalet, Barcelona, 08908, Spain
En recrutement
Hospital General Universitario Gregorio Maranon, Madrid, 28007, Spain
En recrutement
Hospital Universitario Ramon y Cajal, Madrid, 28034, Spain
En recrutement
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
En recrutement
Hospital Regional Universitario de Malaga, Málaga, 29010, Spain
En recrutement
National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, 300195, Taiwan
En recrutement
National Taiwan University Hospital, Taipei, 10016, Taiwan
En recrutement