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

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

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