Clinical trial • Phase I • Oncology

LY4101174 for Advanced/metastatic solid tumor | Solid tumor

Phase I trial of LY4101174 for Advanced/metastatic solid tumor | Solid tumor. None/Not specified-controlled. 340 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced/metastatic solid tumor | Solid tumor
Trial Stage
Phase I
Drug Modality
ADC

Key dates

Initial CTIS Submission Date
31-01-2024
First CTIS Authorization Date
22-05-2024

Trial design

None/Not specified-controlled Phase I trial across 10 sites in Belgium, Spain, France.

Comparator
None/Not specified
Target Sample Size
340

Eligibility

Recruits 340 Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on vulnerable population handling, consent or assent are provided in the source..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on vulnerable population handling, consent or assent are provided in the source.

Recruitment

Planned Sample Size
340
Recruitment Window Months
43
Consent Approach
Not specified in source. Vulnerable population selected; no information on informed consent or assent process, age-specific documents, or available languages is provided.

Geography

Total Number Of Sites
10
Total Number Of Participants
126

Belgium

Earliest CTIS Part Ii Submission Date
24-04-2024
Latest Decision Or Authorization Date
29-08-2025
Processing Time Days
492
Number Of Sites
1
Number Of Participants
23

Sites

Site Name
Institut Jules Bordet
Department Name
001:Oncologie Médicale
Contact Person Name
Nuria Kotecki
Contact Person Email
nuria.kotecki@hubruxelles.be

Spain

Earliest CTIS Part Ii Submission Date
23-04-2024
Latest Decision Or Authorization Date
23-10-2025
Processing Time Days
548
Number Of Sites
4
Number Of Participants
53

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
202:Oncología Médica
Contact Person Name
Daniel Ernesto Castellano Gauna
Contact Person Email
cdanicas@hotmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
203:Oncología
Contact Person Name
Alejandro Falcón González
Contact Person Email
afalconglez@gmail.com
Site Name
MD Anderson Cancer Center
Department Name
201: Oncología
Contact Person Name
Fernando Fabio Franco Pérez
Contact Person Email
ffranco@fundacionmdanderson.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
204:Oncología Médica
Contact Person Name
Rafael Morales Barrera
Contact Person Email
rmorales@vhio.net

France

Earliest CTIS Part Ii Submission Date
08-04-2024
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
584
Number Of Sites
5
Number Of Participants
50

Sites

Site Name
Institut Paoli-Calmettes
Department Name
102: Oncologie Medicale - Cancerolo
Contact Person Name
Renaud Sabatier
Contact Person Email
sabatierr@ipc.unicancer.fr
Site Name
Centre Oscar Lambret
Department Name
105: Cancérologie Générale
Contact Person Name
Loïc Lebellec
Contact Person Email
loic.lebellec@chru-lille.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
106: Medical Oncology
Contact Person Name
Philippe BARTHELEMY
Contact Person Email
p.barthelemy@icans.eu
Site Name
Institut Gustave Roussy
Department Name
104: Département d'innovation Thérapeutique et Essais Précoces (DITEP)
Contact Person Name
Rastislav BAHLEDA
Site Name
Centre Leon Berard
Department Name
101: département d'oncologie médica
Contact Person Name
Armelle VINCENEUX

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
LY4101174
Modality
ADC

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