Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
298
Countries
2
Sites
12
Unresectable, Locally Advanced, or Metastatic Solid Tumors
Key facts
- Sponsor
- Marengo Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Oct 2024 → ongoing
- Decision date (initial)
- 2024-07-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Unresectable, Locally Advanced, or Metastatic Solid Tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Marengo Therapeutics Inc.
- Sponsor organisation
- Marengo Therapeutics Inc.
- Address
- 840 Memorial Drive Floor 4
- City
- Cambridge
- Postcode
- 02139-3771
- Country
- United States
Scientific contact point
- Organisation
- Marengo Therapeutics Inc.
- Contact name
- Ke Liu
Public contact point
- Organisation
- Marengo Therapeutics Inc.
- Contact name
- Ke Liu
Locations
2 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 50 | 5 |
| Spain | Ongoing, recruiting | 30 | 7 |
| Rest of world
Canada, United States
|
— | 218 | — |
Investigational sites
Institut Bergonié
Oncologie Médical, 229 Cours de l'Argonne, 33000, BORDEAUX
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Oncopole Claudius Regaud
Oncologie Médicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Curie
Oncologie Médicale, 26 Rue D Ulm, 75005, Paris
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Quironsalud Madrid
NEXT Madrid Phase I trials, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Fundacion Jimenez Diaz
START Madrid, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Quironsalud Barcelona
Medical Oncology, Placa D'alfonso Comin 5-7, 08023, 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 |
|---|---|---|---|---|---|
| France | 2024-11-04 | 2024-12-16 | |||
| Spain | 2024-10-30 | 2024-11-19 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-19 | France | Acceptable 2024-07-08
|
2024-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-18 | France | Acceptable | 2024-11-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-18 | Acceptable | 2024-11-07 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-19 | France | Acceptable 2025-02-26
|
2025-03-03 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-02 | Acceptable | 2025-04-15 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-10 | France | Acceptable | 2025-07-24 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-29 | France | Acceptable | 2025-09-04 |
| 8 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-03-16 | France | Acceptable 2026-05-18
|
2026-05-18 |