Clinical trial • Phase I • Oncology
Atezolizumab for Advanced and/or metastatic solid tumors
Phase I trial of Atezolizumab for Advanced and/or metastatic solid tumors. None/Not specified-controlled. 36 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced and/or metastatic solid tumors
- Trial Stage
- Phase I
- Drug Modality
- Other | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 11-06-2024
- First CTIS Authorization Date
- 24-07-2024
Trial design
None/Not specified-controlled Phase I trial in Denmark, Belgium, France and others.
- Comparator
- None/Not specified
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 36
Eligibility
Recruits 36 No vulnerable population selected in the provided record; no specific consent or assent handling information provided..
- Vulnerable Population
- No vulnerable population selected in the provided record; no specific consent or assent handling information provided.
Recruitment
- Planned Sample Size
- 36
- Recruitment Window Months
- 57
- Consent Approach
- Informed consent approach not specified in the provided record. No information on assent, who provides consent, age-specific documents, or languages available.
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 61
Denmark
- Earliest CTIS Part Ii Submission Date
- 02-07-2024
- Latest Decision Or Authorization Date
- 25-07-2024
- Processing Time Days
- 23
- Number Of Sites
- 1
- Number Of Participants
- 13
Sites
- Site Name
- Rigshospitalet
- Department Name
- Fase 1 Enhed - Onkologi
- Contact Person Name
- Kristoffer Rohrberg
- Contact Person Email
- kristoffer.staal.rohrberg@regionh.dk
Belgium
- Earliest CTIS Part Ii Submission Date
- 09-07-2024
- Latest Decision Or Authorization Date
- 09-09-2024
- Processing Time Days
- 62
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- UZ Leuven
- Department Name
- Medical Oncology
- Contact Person Name
- Oliver Bechter
- Contact Person Email
- oliver.bechter@uzleuven.be
France
- Earliest CTIS Part Ii Submission Date
- 08-11-2024
- Latest Decision Or Authorization Date
- 09-12-2024
- Processing Time Days
- 31
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Contact Person Name
- Véronique Debien
- Contact Person Email
- v.debien@bordeaux.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Early Phase Trials Unit
- Contact Person Name
- Antoine Italiano
- Contact Person Email
- antoine.italiano@gustaveroussy.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Medical Oncology
- Contact Person Name
- Carlos Gomez Roca
- Contact Person Email
- gomez-roca.carlos@iuct-oncopole.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Contact Person Name
- Philippe Cassier
- Contact Person Email
- philippe.cassier@lyon.unicancer.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 15-10-2024
- Latest Decision Or Authorization Date
- 28-10-2024
- Processing Time Days
- 13
- Number Of Sites
- 4
- Number Of Participants
- 24
Sites
- Site Name
- Clinica Universidad De Navarra (Madrid)
- Department Name
- Oncology
- Contact Person Name
- Ignacio Melero
- Contact Person Email
- imelero@unav.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Victor Moreno
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Elena Garralda
- Contact Person Email
- egarralda@vhio.net
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Oncology
- Contact Person Name
- Ignacio Melero
- Contact Person Email
- imelero@unav.es
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- RO7567132
- Modality
- Other
- Investigational Product Name
- Atezolizumab
- Active Substance
- Atezolizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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