Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
298
Countries
2
Sites
8
Metastatic or locally advanced tumors
Key facts
- Sponsor
- Calico Life Sciences LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Jan 2022 → ongoing
- Decision date (initial)
- 2024-03-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507568-38-00
- EudraCT number
- 2020-005468-78
- ClinicalTrials.gov
- NCT04777994
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic or locally advanced tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Calico Life Sciences LLC
- Sponsor organisation
- Calico Life Sciences LLC
- Address
- 1170 Veterans Boulevard
- City
- South San Francisco
- Postcode
- 94080-1985
- Country
- United States
Scientific contact point
- Organisation
- Calico Life Sciences LLC
- Contact name
- Nancy Dou
Public contact point
- Organisation
- Calico Life Sciences LLC
- Contact name
- Nancy Dou
Locations
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 100 | 5 |
| Spain | Ongoing, recruiting | 100 | 3 |
| Rest of world
Japan, United States, Israel, Korea, Republic of
|
— | 98 | — |
Investigational sites
Hospital Foch
N/A, 40 Rue Worth, 92150, Suresnes
Centre Antoine Lacassagne
N/A, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut Paoli-Calmettes
N/A, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Institut De Cancerologie De L Ouest
Medical oncology, 15 Rue Andre Boquel, 49100, Angers
Institut Universitaire Du Cancer Toulouse-Oncopole
N/A, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Hospital Universitario 12 De Octubre
N/A, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Hm Sanchinarro
N/A, Calle Ona 10, 28050, Madrid
Institut Catala D'oncologia
Unidad de Fase 1, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 |
|---|---|---|---|---|---|
| France | 2023-07-01 | 2023-08-09 | |||
| Spain | 2022-01-14 | 2022-02-23 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-29 | France | Acceptable 2024-03-11
|
2024-03-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-01 | France | Acceptable 2024-08-08
|
2024-09-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-23 | France | Acceptable 2024-11-15
|
2024-11-15 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-11-26 | France | 2024-11-26 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-21 | France | Acceptable 2025-02-26
|
2025-03-03 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-16 | France | Acceptable 2025-06-20
|
2025-06-20 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-20 | France | Acceptable 2025-09-15
|
2025-09-15 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-31 | France | Acceptable 2025-11-13
|
2025-11-13 |