Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Not authorised
Participants planned
85
Countries
1
Sites
4
KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma
Key facts
- Sponsor
- Amal Therapeutics S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2023-06-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10033599 | Pancreatic adenocarcinoma metastatic | 10029104 |
| 21.0 | LLT | 10033602 | Pancreatic adenocarcinoma resectable | 10029104 |
| 21.0 | LLT | 10033600 | Pancreatic adenocarcinoma non-resectable | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amal Therapeutics S.A.
- Sponsor organisation
- Amal Therapeutics S.A.
- Address
- Avenue De La Roseraie 64
- City
- Geneva
- Postcode
- 1205
- Country
- Switzerland
Scientific contact point
- Organisation
- Amal Therapeutics S.A.
- Contact name
- Cristina Riccadonna
Public contact point
- Organisation
- Amal Therapeutics S.A.
- Contact name
- Cristina Riccadonna
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Not authorised | 15 | 4 |
| Rest of world
United States, Switzerland
|
— | 70 | — |
Investigational sites
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-01 | Spain | Not acceptable 2023-06-06
|
2023-06-06 |