Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
256
Countries
1
Sites
10
9 main solid tumors – colorectal, cervical, endometrial, gastric, urothelial, breast, head and neck, ovarian and non-small cell lung cancers.
Key facts
- Sponsor
- Totus Medicines Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Feb 2024 → ongoing
- Decision date (initial)
- 2024-01-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505346-26-01
- ClinicalTrials.gov
- NCT05683418
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
9 main solid tumors – colorectal, cervical, endometrial, gastric, urothelial, breast, head and neck, ovarian and non-small cell lung cancers.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Totus Medicines Inc.
- Sponsor organisation
- Totus Medicines Inc.
- Address
- 1480 64th Street
- City
- Emeryville
- Postcode
- 94608-1183
- Country
- United States
Scientific contact point
- Organisation
- Totus Medicines Inc.
- Contact name
- Zelanna Goldberg
Public contact point
- Organisation
- Totus Medicines Inc.
- Contact name
- Zelanna Goldberg
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 175 | 10 |
| Rest of world
United States
|
— | 81 | — |
Investigational sites
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Vall D Hebron Institute Of Oncology
Oncology, Calle Natzaret 115, 08035, Barcelona
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, 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 |
|---|---|---|---|---|---|
| Spain | 2024-02-19 | 2024-03-06 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-03 | Spain | Acceptable 2024-01-10
|
2024-01-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-21 | Spain | Acceptable 2024-08-06
|
2024-08-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-20 | Spain | Acceptable 2025-01-16
|
2025-01-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-09 | Spain | Acceptable 2025-04-24
|
2025-04-24 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-06 | Spain | Acceptable | 2025-05-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-10 | Spain | Acceptable 2026-04-17
|
2026-04-21 |