Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
630
Countries
4
Sites
12
KRAS G12D-mutant solid tumors.
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
- 6 Feb 2025 → ongoing
- Decision date (initial)
- 2025-01-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516440-25-00
- WHO UTN
- U1111-1312-2152
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
KRAS G12D-mutant 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
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
4 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 55 | 4 |
| Ireland | Ongoing, recruiting | 25 | 1 |
| Italy | Ongoing, recruiting | 55 | 3 |
| Spain | Ongoing, recruiting | 55 | 4 |
| Rest of world
Japan, United States, China, Canada
|
— | 440 | — |
Investigational sites
Universitaetsklinikum Essen AöR
Innere Klinik (Tumorforschung), Hufelandstrasse 55, Holsterhausen, Essen
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CVK), Augustenburger Platz 1, Wedding, Berlin
Technische Universitaet Dresden
Nationales Centrum für Tumorerkrankungen Dresden, Early Clinical Trial Unit (NCT/UCC ECTU), Fetscherstrasse 74, Johannstadt-Nord, Dresden
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOC Oncoematologia AOU Vanvitelli, Via Sergio Pansini 5, 80131, Naples
Centro Ricerche Cliniche Di Verona S.r.l.
Centro Ricerche Cliniche di Verona srl, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Fase I (Unità di Farmacologia Clinica), Largo Francesco Vito 1, 00168, Rome
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
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 | 2025-06-19 | 2025-08-01 | |||
| Ireland | 2025-02-25 | 2025-07-17 | |||
| Italy | 2025-03-11 | 2025-07-15 | |||
| Spain | 2025-02-06 | 2025-07-16 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-13 | Ireland | Acceptable with conditions 2025-01-20
|
2025-01-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-30 | Ireland | Acceptable with conditions 2025-01-20
|
2025-01-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-30 | Ireland | Acceptable with conditions 2025-01-20
|
2025-01-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-06 | Ireland | Acceptable 2025-06-16
|
2025-06-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-01 | Ireland | Acceptable 2025-10-06
|
2025-10-06 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-29 | Acceptable 2025-10-06
|
2025-10-29 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-12 | Ireland | Acceptable 2026-03-02
|
2026-03-02 |