Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
289
Countries
1
Sites
1
Solid Tumors
Key facts
- Sponsor
- Arcus Biosciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Nov 2025 → ongoing
- Decision date (initial)
- 2025-05-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519142-70-00
- ClinicalTrials.gov
- NCT05536141
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid Tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Arcus Biosciences Inc.
- Sponsor organisation
- Arcus Biosciences Inc.
- Address
- 3928 Point Eden Way
- City
- Hayward
- Postcode
- 94545-3719
- Country
- United States
Scientific contact point
- Organisation
- Arcus Biosciences Inc.
- Contact name
- Medical Director
Public contact point
- Organisation
- Arcus Biosciences Inc.
- Contact name
- Medical Director
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 7 | 1 |
| Rest of world
United States, United Kingdom, Korea, Republic of, Australia
|
— | 282 | — |
Investigational sites
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 | 2025-11-19 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-28 | Spain | Acceptable 2025-05-23
|
2025-05-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-04 | Spain | Acceptable 2025-10-21
|
2025-10-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-21 | Spain | Acceptable 2025-10-21
|
2025-11-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-27 | Spain | Acceptable 2026-05-05
|
2026-05-08 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-14 | Spain | Acceptable 2026-05-05
|
2026-05-14 |