Clinical trial • Phase I • Oncology
IDH305 for Advanced malignancies with IDH1 R132 mutation
Phase I trial of IDH305 for Advanced malignancies with IDH1 R132 mutation. 2 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced malignancies with IDH1 R132 mutation
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 28-02-2024
- First CTIS Authorization Date
- 14-03-2024
Trial design
Phase I trial across 2 sites in Germany.
- Biomarker Stratified
- True, biomarker: IDH1 R132 mutation
Eligibility
Recruits 2 Vulnerable population selected; no further details on consent or assent handling provided..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent handling provided.
Recruitment
- Recruitment Window Months
- 136
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 2
Germany
- Earliest CTIS Part Ii Submission Date
- 08-02-2024
- Latest Decision Or Authorization Date
- 29-08-2025
- Processing Time Days
- 568
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- 3001: Abteilung Neuroonkologie, NCT und Neurologische Klinik
- Principal Investigator Name
- Antje Wick
- Principal Investigator Email
- Antje.wick@med.uni-heidelberg.de
- Contact Person Name
- Antje Wick
- Contact Person Email
- Antje.wick@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- 3002: Klinik für Innere Medizin II, Abteilung Hämatologie und internistische Onkologie
- Principal Investigator Name
- Andreas Hochhaus
- Principal Investigator Email
- Andreas.hochhaus@med.uni-jena.de
- Contact Person Name
- Andreas Hochhaus
- Contact Person Email
- Andreas.hochhaus@med.uni-jena.de
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- IDH305
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