Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Not authorised
Participants planned
271
Countries
2
Sites
2
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]
- Decision date (initial)
- 2024-01-15
- 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 · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Not authorised | 23 | 1 |
| Spain | Not authorised | 23 | 1 |
| Rest of world
Canada, United States
|
— | 225 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-01 | France | Not acceptable 2024-01-10
|
2024-01-11 |