Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
94
Countries
3
Sites
9
G12D/G12V Pancreatic Ductal Adenocarcinoma
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Feb 2025 → ongoing
- Decision date (initial)
- 2024-04-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501854-12-01
- ClinicalTrials.gov
- NCT05846516
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
G12D/G12V Pancreatic Ductal Adenocarcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10033600 | Pancreatic adenocarcinoma non-resectable | 10029104 |
| 21.0 | LLT | 10033602 | Pancreatic adenocarcinoma resectable | 10029104 |
| 21.0 | LLT | 10033599 | Pancreatic adenocarcinoma metastatic | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure and Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure and Data Transparency
Locations
3 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 10 | 2 |
| Germany | Ended | 12 | 2 |
| Spain | Ongoing, recruitment ended | 15 | 5 |
| Rest of world
United States, Switzerland
|
— | 57 | — |
Investigational sites
Institut Curie
Department of Medical Oncology, 26 Rue D Ulm, 75005, Paris
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Universitaetsklinikum Heidelberg AöR
Medical Oncology, Im Neuenheimer Feld 672, Neuenheim, Heidelberg
Asklepios Kliniken Hamburg GmbH
Medical Oncology, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
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
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Reina Sofia
Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 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 |
|---|---|---|---|---|---|
| Germany | 2025-05-16 | 2025-06-12 | 2026-02-11 | ||
| Spain | 2025-02-05 | 2025-04-01 | 2026-02-11 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-06 | Spain | Acceptable with conditions 2024-04-01
|
2024-04-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-10 | Spain | Acceptable 2024-08-27
|
2024-08-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-27 | Spain | Acceptable 2024-11-14
|
2024-11-14 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-10 | Spain | Acceptable 2024-11-14
|
2025-01-10 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-02-10 | Spain | Acceptable 2024-11-14
|
2025-02-10 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-02-25 | Spain | Acceptable 2024-11-14
|
2025-02-25 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-07 | Spain | Acceptable | 2025-05-13 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-07 | Acceptable | 2025-04-04 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-07 | Acceptable | 2025-04-22 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-05-14 | Spain | Acceptable | 2025-05-14 |
| 11 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-18 | Spain | Acceptable 2025-10-17
|
2025-10-20 |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-11-13 | Spain | Acceptable 2025-11-14
|
2025-11-14 |
| 13 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-01-15 | Spain | Acceptable 2026-04-23
|
2026-04-24 |