Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
250
Countries
1
Sites
3
Prostate cancer
Key facts
- Sponsor
- ORIC Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Mar 2025 → ongoing
- Decision date (initial)
- 2025-02-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515527-11-00
- ClinicalTrials.gov
- NCT05413421
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Prostate cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
ORIC Pharmaceuticals Inc.
- Sponsor organisation
- ORIC Pharmaceuticals Inc.
- Address
- 240 East Grand Avenue Fl 2
- City
- South San Francisco
- Postcode
- 94080-4811
- Country
- United States
Scientific contact point
- Organisation
- ORIC Pharmaceuticals Inc.
- Contact name
- Pratik Multani
Public contact point
- Organisation
- ORIC Pharmaceuticals Inc.
- Contact name
- ORIC Clinical
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 48 | 3 |
| Rest of world
Australia, United Kingdom, United States
|
— | 202 | — |
Investigational sites
Hospital Universitario Quironsalud Madrid
NEXT Madrid - Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Quironsalud Barcelona
Medical Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitari Vall D Hebron
Medical Oncology Department, 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 |
|---|---|---|---|---|---|
| Spain | 2025-03-20 | 2025-04-10 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-21 | Spain | Acceptable with conditions 2025-01-27
|
2025-02-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-05 | Spain | Acceptable with conditions 2025-01-27
|
2025-02-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-25 | Spain | Acceptable 2025-04-11
|
2025-04-11 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-12 | Spain | Acceptable 2025-04-11
|
2025-06-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-06 | Spain | Acceptable 2025-11-11
|
2025-11-17 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-13 | Spain | Acceptable 2026-04-22
|
2026-04-28 |