Clinical trial • Phase I • Oncology

LY4170156 for Ovarian cancer | Endometrial cancer | Cervical cancer | Non-small cell lung cancer | Triple-negative breast cancer | Pancreatic cancer | Colorectal cancer

Phase I trial of LY4170156 for Ovarian cancer | Endometrial cancer | Cervical cancer | Non-small cell lung cancer | Triple-negative breast cancer | Pancre…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Ovarian cancer | Endometrial cancer | Cervical cancer | Non-small cell lung cancer | Triple-negative breast cancer | Pancreatic cancer | Colorectal cancer
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
22-04-2024
First CTIS Authorization Date
09-08-2024

Trial design

Phase I trial across 8 sites in France, Italy, Spain.

Target Sample Size
316

Eligibility

Recruits 316 Vulnerable population selected: true; no further details on consent or assent handling are provided in the available documents..

Vulnerable Population
Vulnerable population selected: true; no further details on consent or assent handling are provided in the available documents.

Recruitment

Planned Sample Size
316
Recruitment Window Months
37
Consent Approach
Vulnerable population selected; the informed consent and assent process (who provides consent, age-specific documents, languages) is not specified in the available CTIS data.

Geography

Total Number Of Sites
8
Total Number Of Participants
223

France

Earliest CTIS Part Ii Submission Date
01-08-2024
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
596
Number Of Sites
3
Number Of Participants
96

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Contact Person Name
Mario Campone
Contact Person Email
mario.campone@ico.unicancer.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Isabelle Ray-Coquard
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Medical Oncology
Contact Person Name
Carlos Gomez-Roca

Italy

Earliest CTIS Part Ii Submission Date
19-07-2024
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
576
Number Of Sites
2
Number Of Participants
35

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
Gynecologic Oncology Unit
Contact Person Name
Domenica Lorusso
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
Contact Person Name
Giuseppe Curigliano
Contact Person Email
Giuseppe.curigliano@ieo.it

Spain

Earliest CTIS Part Ii Submission Date
10-07-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
552
Number Of Sites
3
Number Of Participants
92

Sites

Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology
Contact Person Name
Jose Alejandro Perez Fidalgo
Contact Person Email
japfidalgo@msn.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Contact Person Name
Ainhoa Madariaga Urrutia
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Roberta Mazzeo
Contact Person Email
robertamazzeo@vhio.net

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
LY4170156

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