Clinical trial • Phase I • Oncology
CUSP06 for Advanced renal cell carcinoma | Platinum-resistant ovarian cancer | CDH6-positive advanced solid tumors
Phase I trial of CUSP06 for Advanced renal cell carcinoma | Platinum-resistant ovarian cancer | CDH6-positive advanced solid tumors.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced renal cell carcinoma | Platinum-resistant ovarian cancer | CDH6-positive advanced solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 17-11-2025
- First CTIS Authorization Date
- 23-03-2026
Trial design
None/Not specified-controlled Phase I trial across 3 sites in Denmark, Spain.
- Comparator
- None/Not specified
- Biomarker Stratified
- True, CDH6 (CDH6-positive)
- Target Sample Size
- 346
Recruitment
- Planned Sample Size
- 346
- Recruitment Window Months
- 17
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 30
Denmark
- Earliest CTIS Part Ii Submission Date
- 20-02-2026
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 38
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Oncology
- Contact Person Name
- Kristoffer Staal Rohrberg
- Contact Person Email
- kristoffer.stahl.rohrberg@regionh.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 24-12-2025
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 96
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Carmen Garcia Duran
- Contact Person Email
- cgarciaduran@vhio.net
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Contact Person Name
- Ramón Yarza Barrio
- Contact Person Email
- ramon.yarza@startmadrid.com
Sponsor
Primary sponsor
- Full Name
- Oncusp Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- CUSP06
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)