Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
190
Countries
3
Sites
17
Clear Cell Renal Cell Carcinoma
Key facts
- Sponsor
- Xencor Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Dec 2025 → ongoing
- Decision date (initial)
- 2024-12-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513619-28-00
- ClinicalTrials.gov
- NCT05433142
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Clear Cell Renal Cell Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10073251 | Clear cell renal cell carcinoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Xencor Inc.
- Sponsor organisation
- Xencor Inc.
- Address
- 465 North Halstead Street Suite 200
- City
- Pasadena
- Postcode
- 91107-3291
- Country
- United States
Scientific contact point
- Organisation
- Xencor Inc.
- Contact name
- Chet Bohac, MD
Public contact point
- Organisation
- Xencor Inc.
- Contact name
- Chet Bohac, MD
Locations
3 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 16 | 4 |
| France | Ongoing, recruiting | 16 | 4 |
| Spain | Ongoing, recruiting | 16 | 9 |
| Rest of world
United States, United Kingdom
|
— | 142 | — |
Investigational sites
UZ Leuven
Oncology, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Az Maria Middelares Gent
Oncology, Buitenring-Sint-Denijs 30, 9000, Gent
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Bordeaux
Medical Oncology, 1 Rue Jean Burguet, 33000, Bordeaux
Institut Paoli Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Hospital Del Mar
Oncology Service, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology Service, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Oncology Service, Pio XII Etorbidea 36, 31008, Pamplona
Parc Tauli Hospital Universitari
Oncology Service, Parc Del Tauli 1, 08208, Sabadell
Clinica Universidad De Navarra
Oncology Service, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario 12 De Octubre
Oncology Service, Avenida De Cordoba Sn, 28041, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology Service, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital De La Santa Creu I Sant Pau
Oncology Service, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitari Vall D Hebron
Oncology Service, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 |
|---|---|---|---|---|---|
| Belgium | 2026-01-15 | 2026-05-04 | |||
| France | 2025-12-11 | 2026-01-23 | |||
| Spain | 2026-01-19 | 2026-02-03 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-26 | France | Acceptable with conditions 2024-12-16
|
2024-12-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-13 | France | Acceptable 2025-09-19
|
2025-09-22 |