Clinical trial • Phase III • Oncology

ADP-A2M4CD8 for Urothelial cancer|Esophageal cancer|Gastric cancer|Non-small cell lung cancer|Head and neck cancer|Ovarian cancer|Melanoma|Endometrial cancer

Phase III trial of ADP-A2M4CD8 for Urothelial cancer|Esophageal cancer|Gastric cancer|Non-small cell lung cancer|Head and neck cancer|Ovarian cancer|Melan…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Urothelial cancer|Esophageal cancer|Gastric cancer|Non-small cell lung cancer|Head and neck cancer|Ovarian cancer|Melanoma|Endometrial cancer
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
08-05-2024
First CTIS Authorization Date
23-05-2024

Trial design

Phase III trial across 9 sites in Spain.

Target Sample Size
88

Eligibility

Recruits 88 Vulnerable population selected; no further details on consent or assent handling are provided in the available records..

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

Recruitment

Planned Sample Size
88
Recruitment Window Months
128

Geography

Total Number Of Sites
9
Total Number Of Participants
32

Spain

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
23-05-2024
Processing Time Days
21
Number Of Sites
9
Number Of Participants
32

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Reyes Bernabe Caro
Contact Person Email
bernabeensayos@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Marc Oliva Bernal
Contact Person Email
moliva@iconcologia.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Victor Moreno Garcia
Contact Person Email
victor.moreno@startmadrid.com
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Mariano Ponz Sarvise
Contact Person Email
mponz@unav.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Elena Garralda Cabanas
Contact Person Email
egarralda@vhio.net
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Andres Cervantes
Contact Person Email
andres.cervantes@uv.es
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Emiliano Calvo Aller
Contact Person Email
emiliano.calvo@startmadrid.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Jon Zugazagoitia Fraile
Contact Person Email
j.zugazagoitia.imas12@h12o.es
Site Name
Hospital Universitario 12 De Octubre (additional entry)
Department Name
Oncology
Contact Person Name
Jon Zugazagoitia Fraile
Contact Person Email
j.zugazagoitia.imas12@h12o.es

Sponsor

Primary sponsor

Full Name
USWM Ct LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
ADP-A2M4CD8

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