Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
376
Countries
2
Sites
3
Advanced renal cell carcinoma (RCC)
Key facts
- Sponsor
- Oncusp Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 May 2026 → ongoing
- Decision date (initial)
- 2026-03-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519862-33-01
- ClinicalTrials.gov
- NCT06234423
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced renal cell carcinoma (RCC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086821 | Advanced renal cell carcinoma | 100000004848 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oncusp Therapeutics Inc.
- Sponsor organisation
- Oncusp Therapeutics Inc.
- Address
- 433 Broadway
- City
- New York
- Postcode
- 10013-2510
- Country
- United States
Scientific contact point
- Organisation
- Oncusp Therapeutics Inc.
- Contact name
- Priya Marreddy
Public contact point
- Organisation
- Oncusp Therapeutics Inc.
- Contact name
- Priya Marreddy
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 15 | 1 |
| Spain | Authorised, recruiting | 15 | 2 |
| Rest of world
United States, Australia, United Kingdom
|
— | 346 | — |
Investigational sites
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2026-05-18 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-17 | Denmark | Acceptable 2026-03-23
|
2026-03-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-30 | Denmark | Acceptable 2026-03-23
|
2026-03-30 |