Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
173
Countries
1
Sites
3
Advanced or Metastatic Solid Tumors
Key facts
- Sponsor
- Moma Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Mar 2025 → ongoing
- Decision date (initial)
- 2025-02-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513502-62-00
- ClinicalTrials.gov
- NCT06545942
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or Metastatic Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Moma Therapeutics Inc.
- Sponsor organisation
- Moma Therapeutics Inc.
- Address
- 20 Acorn Park Drive
- City
- Cambridge
- Postcode
- 02140-2131
- Country
- United States
Scientific contact point
- Organisation
- Moma Therapeutics Inc.
- Contact name
- Marc Ballas
Public contact point
- Organisation
- Moma Therapeutics Inc.
- Contact name
- Marc Ballas
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 48 | 3 |
| Rest of world
United Kingdom, United States
|
— | 125 | — |
Investigational sites
Institut Catala D'oncologia
Servicio de oncologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Fundacion Jimenez Diaz
Servicio de oncologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Servicio de oncologia, Passeig De La Vall D'Hebron 119-129, 08035, 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 |
|---|---|---|---|---|---|
| Spain | 2025-03-07 | 2025-04-25 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-30 | Spain | Acceptable with conditions 2025-02-14
|
2025-02-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-07 | Spain | Acceptable 2025-07-16
|
2025-07-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-31 | Spain | Acceptable 2025-07-16
|
2025-07-31 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-05 | Spain | Acceptable with conditions 2025-10-03
|
2025-10-06 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-18 | Spain | Acceptable 2026-01-19
|
2026-01-23 |