Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
750
Countries
5
Sites
18
Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumor Metastatic Solid Tumor, PanKRAS.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 May 2025 → ongoing
- Decision date (initial)
- 2024-11-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516733-12-00
- WHO UTN
- U1111-1309-9988
- ClinicalTrials.gov
- NCT06607185
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumor Metastatic Solid Tumor, PanKRAS.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Eli Lilly & Co.
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Eli Lilly & Co.
Locations
5 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 33 | 3 |
| France | Ended | 72 | 2 |
| Germany | Ended | 100 | 5 |
| Italy | Ended | 50 | 1 |
| Spain | Ongoing, recruitment ended | 98 | 7 |
| Rest of world
China, United States, Japan, Taiwan
|
— | 397 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Oncology, Corneel Heymanslaan 10, 9000, Gent
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
DITEP Drug Development Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Asklepios Kliniken Hamburg GmbH
Onkologie und Palliativmedizin, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
Krankenhaus Nordwest GmbH
Institut für Klinisch-Onkologische Forschung (IKF), Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Universitaetsklinikum Wuerzburg AöR
Interdisziplinäres Studienzentrum (ISZ) mit ECTU, Josef-Schneider-Strasse 6, Grombuehl, Wuerzburg
SLK-Kliniken Heilbronn GmbH
Medizinische Klinik III, Am Gesundbrunnen 20-26, Neckargartach, Heilbronn
Charite Universitaetsmedizin Berlin KöR
Klinik für Hämatologie und Onkologie, ECTU, Hindenburgdamm 30, Lichterfelde, Berlin
Centro Ricerche Cliniche Di Verona S.r.l.
Oncology Unit, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Regional De Malaga
Medical Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Del Mar
Medical Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, 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 |
|---|---|---|---|---|---|
| Belgium | 2025-05-13 | 2025-08-05 | 2026-02-19 | ||
| France | 2025-12-01 | ||||
| Germany | 2025-07-10 | 2025-08-07 | 2026-02-19 | ||
| Italy | 2025-08-04 | 2025-10-20 | 2026-02-19 | ||
| Spain | 2025-06-12 | 2025-08-06 | 2026-02-19 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-10 | Belgium | Acceptable with conditions 2024-11-20
|
2024-11-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-30 | Belgium | Acceptable 2025-02-18
|
2025-02-18 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-03-05 | 2025-05-08 | ||
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-03-20 | Acceptable 2025-02-18
|
2025-06-04 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-04-04 | Acceptable 2025-02-18
|
2025-06-27 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-04-17 | Acceptable 2025-02-18
|
2025-06-27 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-28 | Acceptable 2025-02-18
|
2025-07-28 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-14 | Belgium | Acceptable 2025-11-07
|
2025-11-07 |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-23 | Belgium | Acceptable 2026-02-24
|
2026-02-24 |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-05-04 | Acceptable 2026-06-01
|
2026-06-03 |