Clinical trial • Phase I • Oncology

Atezolizumab for Locally advanced or metastatic solid tumor|Ovarian cancer|Clear cell renal cell carcinoma

Phase I trial of Atezolizumab for Locally advanced or metastatic solid tumor|Ovarian cancer|Clear cell renal cell carcinoma. None/Not specified-controlled.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Locally advanced or metastatic solid tumor|Ovarian cancer|Clear cell renal cell carcinoma
Trial Stage
Phase I
Drug Modality
Monoclonal antibody|Other

Key dates

Initial CTIS Submission Date
22-10-2024
First CTIS Authorization Date
18-02-2025

Trial design

None/Not specified-controlled Phase I trial across 7 sites in Spain, Czechia.

Comparator
None/Not specified
Target Sample Size
111

Eligibility

Recruits 111 Vulnerable population not selected; no vulnerable population consent or assent handling specified..

Vulnerable Population
Vulnerable population not selected; no vulnerable population consent or assent handling specified.

Recruitment

Planned Sample Size
111
Recruitment Window Months
12

Geography

Total Number Of Sites
7
Total Number Of Participants
23

Spain

Earliest CTIS Part Ii Submission Date
05-11-2024
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
505
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Servicio de oncologia
Contact Person Name
Bernard Doger de Speville Uribe
Contact Person Email
bernard.doger@startmadrid.com
Site Name
Clinica Universidad De Navarra
Department Name
Servicio de oncologia
Contact Person Name
Ignacio Melero Bermejo
Contact Person Email
imelero@unav.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Servicio de oncologia
Contact Person Name
Andres Cervantes Ruiperez
Contact Person Email
andres.cervantes@uv.es
Site Name
Clinica Universidad De Navarra
Department Name
Servicio de oncologia
Contact Person Name
Ignacio Melero Bermejo
Contact Person Email
imelero@unav.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de oncologia
Contact Person Name
Cristina Suarez Rodriguez
Contact Person Email
csuarez@vhio.net

Czechia

Earliest CTIS Part Ii Submission Date
18-02-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
405
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
University Hospital Olomouc
Contact Person Name
Bohuslav Melichar
Contact Person Email
Bohuslav.melichar@fnol.cz
Site Name
Masarykuv Onkologicky Ustav
Contact Person Name
Radka Lordick Obermannová
Contact Person Email
obermannova@mou.cz

Sponsor

Primary sponsor

Full Name
Genentech Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
RO7566802
Modality
Other
Investigational Product Name
Atezolizumab
Active Substance
Atezolizumab
Modality
Monoclonal antibody
Combination Treatment
Yes

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