Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
149
Countries
1
Sites
6
Other Solid Tumors Associated with Nectin-4 Expression
Key facts
- Sponsor
- Rondo Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-06-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-524687-38-00
- ClinicalTrials.gov
- NCT07218003
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Other Solid Tumors Associated with Nectin-4 Expression
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10046730 | Urothelial carcinoma urethra metastatic | 10029104 |
| 28.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 27.0 | LLT | 10046728 | Urothelial carcinoma urethra | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rondo Therapeutics Inc.
- Sponsor organisation
- Rondo Therapeutics Inc.
- Address
- 25801 Industrial Boulevard Suite 500
- City
- Hayward
- Postcode
- 94545-2245
- Country
- United States
Scientific contact point
- Organisation
- Rondo Therapeutics Inc.
- Contact name
- Thomas Manley, MD
Public contact point
- Organisation
- Rondo Therapeutics Inc.
- Contact name
- Thomas Manley, MD
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 34 | 6 |
| Rest of world
United States, United Kingdom
|
— | 115 | — |
Investigational sites
Hospital Universitario Hm Sanchinarro
Centro Integral Oncológico Clara Campal (CIOCC); START Madrid, Calle Ona 10, 28050, Madrid
Hospital Clinico Universitario De Valencia
Oncología Medica, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Quironsalud Madrid
Oncología Médica; Next Oncology Madrid, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Clinic De Barcelona
Oncología Medica, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Quironsalud Barcelona
Oncología Médica, Placa D'alfonso Comin 5-7, 08023, Barcelona
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-15 | Spain | Acceptable 2026-06-16
|
2026-06-17 |