Clinical trial • Phase I • Oncology
Clinical trial in Platinum-resistant ovarian cancer | CDH6-positive advanced solid tumors | Advanced renal cell carcinoma
Phase I trial for Platinum-resistant ovarian cancer | CDH6-positive advanced solid tumors | Advanced renal cell carcinoma. 177 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Platinum-resistant ovarian cancer | CDH6-positive advanced solid tumors | Advanced renal cell carcinoma
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 11-03-2025
- First CTIS Authorization Date
- 18-06-2025
Trial design
Phase I trial across 2 sites in Denmark, Spain.
- Biomarker Stratified
- True, biomarker: CDH6 (CDH6-positive tumors)
- Target Sample Size
- 177
Eligibility
Recruits 177 Vulnerable population selected; no further details on consent or assent handling provided in the available documentation..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent handling provided in the available documentation.
Recruitment
- Planned Sample Size
- 177
- Recruitment Window Months
- 27
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 20
Denmark
- Earliest CTIS Part Ii Submission Date
- 09-06-2025
- Latest Decision Or Authorization Date
- 18-06-2025
- Processing Time Days
- 9
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Oncology
- Principal Investigator Name
- Kristoffer Staal Rohrberg
- Principal Investigator Email
- kristoffer.stahl.rohrberg@regionh.dk
- Contact Person Name
- Kristoffer Staal Rohrberg
- Contact Person Email
- kristoffer.stahl.rohrberg@regionh.dk
- Number Of Participants
- 10
Spain
- Earliest CTIS Part Ii Submission Date
- 06-06-2025
- Latest Decision Or Authorization Date
- 23-06-2025
- Processing Time Days
- 17
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Ana Oaknin Benzaquen
- Principal Investigator Email
- aoaknin@vhio.net
- Contact Person Name
- Ana Oaknin Benzaquen
- Contact Person Email
- aoaknin@vhio.net
- Number Of Participants
- 10
Sponsor
Primary sponsor
- Full Name
- Oncusp Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
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