Clinical trial • Phase I • Oncology
OATD-02 for Colorectal cancer | Ovarian cancer | Pancreatic cancer | Renal cell carcinoma
Phase I trial of OATD-02 for Colorectal cancer | Ovarian cancer | Pancreatic cancer | Renal cell carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Colorectal cancer | Ovarian cancer | Pancreatic cancer | Renal cell carcinoma
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 15-03-2024
- First CTIS Authorization Date
- 12-04-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 3 sites in Poland.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True - includes dose-escalation (first-in-human); specific escalation rules, interim analyses or stopping rules not provided.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 40
Eligibility
Recruits 40 Vulnerable population selected; consent/assent handling not specified..
- Vulnerable Population
- Vulnerable population selected; consent/assent handling not specified.
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 40
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 40
Poland
- Earliest CTIS Part Ii Submission Date
- 29-03-2024
- Latest Decision Or Authorization Date
- 18-08-2025
- Processing Time Days
- 507
- Number Of Sites
- 3
- Number Of Participants
- 40
Sites
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemioterapii
- Principal Investigator Name
- Bogdan Żurawski
- Principal Investigator Email
- zurawskib@co.bydgoszcz.pl
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- zurawskib@co.bydgoszcz.pl
- Site Name
- Lux Med Onkologia Sp. z o.o.
- Department Name
- Oddział Onkologii Klinicznej/Chemioterapii
- Principal Investigator Name
- Maciej Studziński
- Principal Investigator Email
- maciejstudzinski@pm.me
- Contact Person Name
- Maciej Studziński
- Contact Person Email
- maciejstudzinski@pm.me
- Site Name
- Europejskie Centrum Zdrowia Otwock Sp. z o.o.
- Department Name
- Klinika Onkologii
- Principal Investigator Name
- Cezary Szczylik
- Principal Investigator Email
- cezary.szczylik@ecz-otwock.pl
- Contact Person Name
- Cezary Szczylik
- Contact Person Email
- cezary.szczylik@ecz-otwock.pl
Sponsor
Primary sponsor
- Full Name
- Molecure S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Poland
Investigational products
- Investigational Product Name
- OATD-02
- First In Human
- Yes
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