Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
94
Countries
2
Sites
7
Multiple Myeloma
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
- 13 Dec 2022 → 26 Aug 2025
- Decision date (initial)
- 2024-05-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511116-25-00
- EudraCT number
- 2021-005589-16
- ClinicalTrials.gov
- NCT04772989
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
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
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 7 | 2 |
| Spain | Ended | 11 | 5 |
| Rest of world
United States
|
— | 76 | — |
Investigational sites
Med Polonia Sp. z o.o.
N/A, Obornicka 262, 60-693, Poznan
Hlk Sp. z o.o.
N/A, Ul. Witolda Chodzki 17/6, 20-093, Lublin
Hospital Universitario 12 De Octubre
Servicio de Oncologia Medica, Bloque D, Avenida De Cordoba Sn, Madrid
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
Materno Infantil, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Start Unit, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
Departamento De Oncología, Avenue Pio XII 36, 31008, Pamplona
Clinica Universidad De Navarra
N/A, Calle Marquesado De Santa Marta 1, 28027, Madrid
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 |
|---|---|---|---|---|---|
| Poland | 2022-12-13 | 2023-03-16 | 2023-06-01 | ||
| Spain | 2023-01-04 | 2023-01-05 | 2023-04-13 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-02 | Spain | Acceptable 2024-05-10
|
2024-05-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-05 | Spain | Acceptable 2024-11-04
|
2024-11-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-16 | Spain | Acceptable 2025-02-24
|
2025-02-24 |