Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
23
Countries
2
Sites
3
Patients with IDH1 R132, IDH2 R140 or IDH2 R172-mutant advanced solid tumor types, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma.
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
- 19 Jan 2021 → ongoing
- Decision date (initial)
- 2024-10-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515150-24-00
- EudraCT number
- 2020-002863-77
- ClinicalTrials.gov
- NCT04521686
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with IDH1 R132, IDH2 R140 or IDH2 R172-mutant advanced solid tumor types, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma.
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
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 2 | 2 |
| Spain | Ongoing, recruitment ended | 1 | 1 |
| Rest of world
Hong Kong, Australia, Taiwan, United States, Singapore, Japan
|
— | 20 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| France | 2021-01-19 | 2021-04-13 | 2023-03-31 | ||
| Spain | 2021-04-20 | 2021-05-03 | 2023-12-23 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-12 | France | Acceptable 2024-10-29
|
2024-10-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-20 | France | Acceptable 2025-01-08
|
2025-01-08 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-31 | France | Acceptable 2025-01-08
|
2025-03-31 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-23 | Acceptable 2025-01-08
|
2025-04-23 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-14 | Acceptable | 2026-01-20 |