Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Temporarily halted
Participants planned
420
Countries
2
Sites
5
Advanced or Metastatic Urothelial Carcinoma or Other 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
- 30 Oct 2025 → ongoing
- Decision date (initial)
- 2024-08-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or Metastatic Urothelial Carcinoma or Other 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
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Temporarily halted | 25 | 1 |
| Spain | Temporarily halted | 70 | 4 |
| Rest of world
Australia, United Kingdom, Korea, Republic of, China, Japan, United States
|
— | 325 | — |
Investigational sites
Hospital Universitario Hm Sanchinarro
Oncología, Calle Ona 10, 28050, Madrid
University Hospital Virgen Del Rocio S.L.
Oncología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Institut Catala D'oncologia
Oncología, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
Oncología, Bloque D, Avenida De Cordoba Sn, 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 |
|---|---|---|---|---|---|
| France | 2025-03-10 | ||||
| Spain | 2024-09-23 | 2024-10-17 | 2025-04-04 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 4 · Art. 38 CTR
Temporary halt TH-113665
- Halt date
- 2025-12-23
- Member states concerned
- France
- Publication date
- 2026-01-07
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Explanation
- Please refer to the cover letter enclosed.
- Follow-up measures
- For additional information, please see attached cover letter.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-113664
- Halt date
- 2025-12-23
- Member states concerned
- Spain
- Publication date
- 2026-01-07
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Explanation
- Please refer to the cover letter enclosed.
- Follow-up measures
- For additional information, please see attached cover letter.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-78936
- Halt date
- 2025-04-04
- Member states concerned
- France
- Publication date
- 2025-04-11
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- For additional information, please see attached cover letter.
- Follow-up measures
- For additional information, please see attached cover letter.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-78934
- Halt date
- 2025-04-04
- Member states concerned
- Spain
- Publication date
- 2025-04-11
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- For additional information, please see attached cover letter.
- Follow-up measures
- For additional information, please see attached cover letter.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-14 | Spain | Acceptable with conditions 2024-08-12
|
2024-08-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-27 | Acceptable with conditions | 2024-11-20 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-25 | Spain | Acceptable with conditions | 2024-11-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-08 | Spain | Acceptable 2025-03-27
|
2025-03-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-02 | Spain | Acceptable | 2025-04-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-05 | Spain | Acceptable 2025-10-30
|
2025-10-30 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-20 | Spain | Acceptable | 2025-12-03 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-02 | Acceptable | 2026-01-14 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-04-15 | Acceptable 2026-05-26
|
2026-05-28 |