Clinical trial • Phase I • Oncology
MYB mRNA degrader for Adenoid cystic carcinoma
Phase I trial of MYB mRNA degrader for Adenoid cystic carcinoma. open-label. 70 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Adenoid cystic carcinoma
- Trial Stage
- Phase I
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 29-01-2024
- First CTIS Authorization Date
- 06-05-2024
Trial design
open-label Phase I trial across 5 sites in France.
- Open Label
- Yes
- Target Sample Size
- 70
Eligibility
Recruits 70 Vulnerable population selected; no details on consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 70
- Recruitment Window Months
- 48
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 70
France
- Earliest CTIS Part Ii Submission Date
- 13-03-2024
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 791
- Number Of Sites
- 5
- Number Of Participants
- 30
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Oncologie Médicale
- Contact Person Name
- Laurence Digue
- Contact Person Email
- laurence.digue@chu-bordeaux.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Cancérologie Cervico-Faciale
- Contact Person Name
- Caroline Even
- Contact Person Email
- caroline.even@gustaveroussy.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Unité de Phase Précoce
- Contact Person Name
- Esma Saada-Bouzid
- Contact Person Email
- esma.saada-bouzid@nice.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie Médicale
- Contact Person Name
- Jérôme Fayette
- Contact Person Email
- jerome.fayette@lyon.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Oncologie Médicale
- Contact Person Name
- Frédéric Rolland
- Contact Person Email
- frederic.rolland@ico.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Remix Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- REM-422
- Active Substance
- MYB mRNA degrader
- Modality
- Other
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