Clinical trial • Phase I • Oncology

ABBV-969 for Prostate cancer | Metastatic castration-resistant prostate cancer

Phase I trial of ABBV-969 for Prostate cancer | Metastatic castration-resistant prostate cancer. None/Not specified-controlled. 194 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Prostate cancer | Metastatic castration-resistant prostate cancer
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
30-01-2025
First CTIS Authorization Date
23-05-2025

Trial design

None/Not specified-controlled Phase I trial in France, Spain.

Comparator
None/Not specified
Target Sample Size
194

Eligibility

Recruits 194 Vulnerable population not selected; no consent or assent details provided..

Vulnerable Population
Vulnerable population not selected; no consent or assent details provided.

Recruitment

Planned Sample Size
194
Recruitment Window Months
24

Geography

Total Number Of Sites
6
Total Number Of Participants
36

France

Earliest CTIS Part Ii Submission Date
09-05-2025
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
313
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Centre Oscar Lambret
Department Name
Département d’Oncologie Médicale
Principal Investigator Name
Aurélien CARNOT
Principal Investigator Email
a-carnot@o-lambret.fr
Contact Person Name
Aurélien CARNOT
Contact Person Email
a-carnot@o-lambret.fr
Site Name
Institut Gustave Roussy
Department Name
Département d’Innovation Thérapeutique et d’Essais Précoces (DITEP)
Principal Investigator Name
Christope MASSARD
Principal Investigator Email
christophe.massard@gustaveroussy.fr
Contact Person Name
Christope MASSARD
Site Name
Centre Leon Berard
Department Name
Department of Medical Oncology
Principal Investigator Name
Armelle VINCENEUX
Principal Investigator Email
Armelle.vinceneux@lyon.unicancer.fr
Contact Person Name
Armelle VINCENEUX

Spain

Earliest CTIS Part Ii Submission Date
10-05-2025
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
311
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology Department
Principal Investigator Name
Joaquin Mateo Valderrama
Principal Investigator Email
jmateo@vhio.net
Contact Person Name
Joaquin Mateo Valderrama
Contact Person Email
jmateo@vhio.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology Service
Principal Investigator Name
Begoña Pérez Valderrama
Principal Investigator Email
bpvalderrama@gmail.com
Contact Person Name
Begoña Pérez Valderrama
Contact Person Email
bpvalderrama@gmail.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Medical Oncology Service
Principal Investigator Name
Irene Moreno Candilejo
Principal Investigator Email
irene.moreno@startmadrid.com
Contact Person Name
Irene Moreno Candilejo
Contact Person Email
irene.moreno@startmadrid.com

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
ABBV-969
Routes Of Administration
Intravenously (IV) infusion
Route
Intravenous
First In Human
Yes

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