Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
341
Countries
2
Sites
10
Advanced solid tumors
Key facts
- Sponsor
- Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Sep 2025 → 9 Jan 2026
- Decision date (initial)
- 2024-04-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507905-33-00
- ClinicalTrials.gov
- NCT00161943
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
| 20.0 | LLT | 10078787 | Tumor inflammation | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- Kaiser-Wilhelm-Allee 1, Wiesdorf Wiesdorf
- City
- Leverkusen
- Postcode
- 51373
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
2 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 37 | 4 |
| Spain | Ended | 60 | 6 |
| Rest of world
United Kingdom, China, United States, Korea, Republic of, Japan
|
— | 244 | — |
Investigational sites
Centre hospitalier universitaire de Liege
Medical Oncology, Avenue De L'Hopital 1, 4000, Liege
Universitair Ziekenhuis Gent
Drug Research Unit, Corneel Heymanslaan 10, 9000, Gent
Institut Jules Bordet
Medical Oncology / Clinical Trials Conduct Unit, Mijlenmeersstraat 90, 1070, Anderlecht
Antwerp University Hospital
Oncologie, Drie Eikenstraat 655, 2650, Edegem
Hospital Universitario Fundacion Jimenez Diaz
Phase I Clinical Trials, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Departament d'Oncología Médica, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Hm Nou Delfos
Early Phase Unit, Avinguda De Vallcarca 151, 08023, Barcelona
Clinica Universidad De Navarra
Unidad de Ensayos Clínicos, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Hm Sanchinarro
Early phase drug development, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Unidad de Ensayos Clínicos, Avenue Pio XII 36, 31008, Pamplona
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 | 2024-07-31 | 2025-09-30 | 2024-08-13 | 2025-09-30 | |
| Spain | 2024-07-19 | 2026-01-09 | 2024-08-23 | 2025-09-30 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-85375
- Halt date
- 2025-06-02
- Member states concerned
- Belgium
- Publication date
- 2025-06-04
- Reason
- Sponsor decision
- Explanation
- The trial's sponsor, Bayer AG, has taken a decision to cease further development of the BAY2965501 (DGKz) compound. As a result, the recruitment for the clinical trial 21948 (EU CT number: 2023-507905-33-00; IND: 161943) is temporarily halted.
Future progress of the trial will be assessed and determined in alignment with Bayer’s licensor of relevant IP covering the BAY2965501 (DGKz) compound. - Follow-up measures
- The risk-benefit ratio remains favourable. Therefore, all current enrolled patients will continue to receive treatment and examinations as outlined in the protocol. Participating investigators have been informed on 02 June 2025 about the temporary recruitment halt.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-85373
- Halt date
- 2025-06-02
- Member states concerned
- Spain
- Publication date
- 2025-06-04
- Reason
- Sponsor decision
- Explanation
- The trial's sponsor, Bayer AG, has taken a decision to cease further development of the BAY2965501 (DGKz) compound. As a result, the recruitment for the clinical trial 21948 (EU CT number: 2023-507905-33-00; IND: 161943) is temporarily halted.
Future progress of the trial will be assessed and determined in alignment with Bayer’s licensor of relevant IP covering the BAY2965501 (DGKz) compound. - Follow-up measures
- The risk-benefit ratio remains favourable. Therefore, all current enrolled patients will continue to receive treatment and examinations as outlined in the protocol. Participating investigators have been informed on 02 June 2025 about the temporary recruitment halt.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-18 | Belgium | Acceptable 2024-04-12
|
2024-04-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-06 | Belgium | Acceptable 2024-07-18
|
2024-07-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-08 | Acceptable | 2024-08-09 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-07 | Belgium | Acceptable 2024-12-18
|
2024-12-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-19 | Belgium | Acceptable with conditions 2025-06-04
|
2025-06-04 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-19 | Belgium | Acceptable 2025-11-26
|
2025-12-01 |