Clinical trial • Phase I • Oncology
DKY709 for Nasopharyngeal carcinoma|Triple-negative breast cancer|Microsatellite stable colorectal cancer|Non-small cell lung cancer|Cutaneous melanoma
Phase I trial of DKY709 for Nasopharyngeal carcinoma|Triple-negative breast cancer|Microsatellite stable colorectal cancer|Non-small cell lung cancer|Cuta…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Nasopharyngeal carcinoma|Triple-negative breast cancer|Microsatellite stable colorectal cancer|Non-small cell lung cancer|Cutaneous melanoma
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 09-07-2024
- First CTIS Authorization Date
- 08-08-2024
Trial design
Phase I trial across 2 sites in Spain, Germany.
- Target Sample Size
- 66
Eligibility
Recruits 66 Vulnerable population selected; no details provided on consent or assent handling..
- Vulnerable Population
- Vulnerable population selected; no details provided on consent or assent handling.
Recruitment
- Planned Sample Size
- 66
- Recruitment Window Months
- 76
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 32
Spain
- Earliest CTIS Part Ii Submission Date
- 09-07-2024
- Latest Decision Or Authorization Date
- 04-06-2025
- Processing Time Days
- 330
- Number Of Sites
- 1
- Number Of Participants
- 19
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- #9000:Oncología Médica
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
Germany
- Earliest CTIS Part Ii Submission Date
- 09-07-2024
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 657
- Number Of Sites
- 1
- Number Of Participants
- 13
Sites
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- #3001:Medizinische Klinik I NCT / UCC-Early Clinical Trial Unit
- Contact Person Name
- Martin Wermke
- Contact Person Email
- Martin.wermke@uniklinikum-dresden.de
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- DKY709
- Investigational Product Name
- PDR001
- Combination Treatment
- Yes
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