Clinical trial • Phase I • Oncology

LY4066434 for Pancreatic ductal adenocarcinoma | Non-small cell lung cancer | Colorectal cancer | Advanced solid tumor | Metastatic solid tumor | KRAS-mutant solid tumor

Phase I trial of LY4066434 for Pancreatic ductal adenocarcinoma | Non-small cell lung cancer | Colorectal cancer | Advanced solid tumor | Metastatic solid…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Pancreatic ductal adenocarcinoma | Non-small cell lung cancer | Colorectal cancer | Advanced solid tumor | Metastatic solid tumor | KRAS-mutant solid tumor
Trial Stage
Phase I
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
10-10-2024
First CTIS Authorization Date
20-11-2024

Trial design

Phase I trial across 18 sites in Belgium, Spain, Germany and others.

Target Sample Size
397

Recruitment

Planned Sample Size
397
Recruitment Window Months
59

Geography

Total Number Of Sites
18
Total Number Of Participants
353

Belgium

Earliest CTIS Part Ii Submission Date
08-11-2024
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
473
Number Of Sites
3
Number Of Participants
33

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Oncology
Contact Person Name
Rachel Galot
Site Name
Institut Jules Bordet
Department Name
Oncology
Contact Person Name
Nuria Kotecki
Contact Person Email
nuria.kotecki@hubruxelles.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Oncology
Contact Person Name
Sylvie Rottey
Contact Person Email
sylvie.rottey@uzgent.be

Spain

Earliest CTIS Part Ii Submission Date
22-04-2025
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
314
Number Of Sites
7
Number Of Participants
98

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Elena Garralda
Contact Person Email
egarralda@vhio.net
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Ramon Salazar
Contact Person Email
ramonsalazar@iconcologia.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Contact Person Name
Federico Longo
Contact Person Email
fedelongomunoz@hotmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Contact Person Name
Santiago Ponce
Contact Person Email
santiago.ponce@oncosur.org
Site Name
Hospital Universitario Regional De Malaga
Department Name
Medical Oncology
Contact Person Name
Julia Alcaide
Contact Person Email
drayulia@hotmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology
Contact Person Name
Antonio Calles
Site Name
Hospital Del Mar
Department Name
Medical Oncology
Contact Person Name
Edurne Arriola
Contact Person Email
earriola@parcdesalutmar.cat

Germany

Earliest CTIS Part Ii Submission Date
11-04-2025
Latest Decision Or Authorization Date
25-02-2026
Processing Time Days
320
Number Of Sites
5
Number Of Participants
100

Sites

Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Onkologie und Palliativmedizin
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Interdisziplinäres Studienzentrum (ISZ) mit ECTU
Contact Person Name
Barbara Deschler-Baier
Contact Person Email
deschler_b@ukw.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Hämatologie und Onkologie, ECTU
Contact Person Name
Damian Rieke
Contact Person Email
damian.rieke@charite.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Medizinische Klinik III
Contact Person Name
Uwe Martens
Contact Person Email
uwe.martens@slk-kliniken.de
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung (IKF)
Contact Person Name
Thorsten Götze
Contact Person Email
goetze.thorsten@khnw.de

France

Earliest CTIS Part Ii Submission Date
13-05-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
287
Number Of Sites
2
Number Of Participants
72

Sites

Site Name
Institut Gustave Roussy
Department Name
DITEP Drug Development Department
Contact Person Name
Antoine Hollebecque
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Philippe Cassier

Italy

Earliest CTIS Part Ii Submission Date
27-05-2025
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
283
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Oncology Unit
Contact Person Name
Davide Melisi
Contact Person Email
davide.melisi@univr.it

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
LY4066434
Active Substance
LY4066434
Modality
Small molecule

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