Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
186
Countries
6
Sites
22
solid tumors
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 May 2025 → ongoing
- Decision date (initial)
- 2024-07-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512504-19-00
- EudraCT number
- 2020-003902-30
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
solid tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Locations
6 EU/EEA countries · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Temporarily halted | 10 | 2 |
| Belgium | Temporarily halted | 16 | 3 |
| France | Temporarily halted | 42 | 5 |
| Germany | Temporarily halted | 22 | 4 |
| Italy | Authorised, recruitment pending | 7 | 3 |
| Spain | Temporarily halted | 25 | 5 |
| Rest of world
United States, Switzerland, Canada, Australia
|
— | 64 | — |
Investigational sites
Medizinische Universitaet Innsbruck
Univ.-Klinik für Innere Medizin V, Hämatologie und Onkologie, Anichstrasse 35, 6020, Innsbruck
SCRI CCCIT Ges.m.b.H.
Center for Clinical Cancer and Immunology Trials (CCCIT), Muellner Hauptstrasse 48, 5020, Salzburg
Antwerp University Hospital
Oncologie UZA, Drie Eikenstraat 655, 2650, Edegem
UZ Leuven
General Medical Oncology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Medical Oncology, Corneel Heymanslaan 10, 9000, Gent
Institut Gustave Roussy
Département d'Innovation Thérapeutique et d’Essais Précoces - DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre De Lutte Contre Le Cancer Eugene Marquis
Département d'Oncologie Médicale, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Institut Bergonie
Service Oncologie, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Hospitalier Regional De Marseille
Unité de Phase I Oncologie labélisée CLIP, 264 Rue Saint Pierre, 13005, Marseille
Assistance Publique Hopitaux De Paris
Service Dermatologie, 1 Avenue Claude Vellefaux, 75010, Paris
Universitaetsklinikum Heidelberg AöR
Service d'Oncologie Multidisciplinaire et Innovation thérapeutique, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Charite Universitaetsmedizin Berlin KöR
Charité Comprehensive Cancer Center, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Tuebingen AöR
Medizinische Klinik Innere Medizin VIII, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Universitaetsklinikum Ulm AöR
Comprehensive Cancer Center Ulm (CCCU), Albert-Einstein-Allee 23, Eselsberg, Ulm
Centro Ricerche Cliniche Di Verona S.r.l.
Azienda Ospedaliera Universitaria Integrata Verona, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
ASST Grande Ospedale Metropolitano Niguarda
S.C. Divisione Oncologia Medica Falck, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Trapianti e Terapia cellulare, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Fundacion Instituto Valenciano De Oncologia
Servicio de Farmacia, Calle Professor Beltran Baguena 8, 46009, Valencia
Institut Catala D'oncologia
Servicio de Oncología Médica, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Quironsalud Barcelona
Next Oncology Barcelona IOB, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Servicio de Oncología Médica, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
Servicio de Oncología Médica, 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 |
|---|---|---|---|---|---|
| Austria | 2023-07-13 | 2024-02-19 | 2026-05-11 | ||
| Belgium | 2023-04-26 | 2023-08-08 | 2026-05-11 | ||
| France | 2022-11-29 | 2023-03-09 | 2026-05-11 | ||
| Germany | 2023-10-13 | 2024-02-28 | 2026-05-11 | ||
| Spain | 2023-02-03 | 2023-05-11 | 2026-05-11 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 10 · Art. 38 CTR
Temporary halt TH-133926
- Halt date
- 2026-05-11
- Member states concerned
- Austria
- Publication date
- 2026-05-13
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Please refer to the attached notification letter
- Follow-up measures
- Please refer to the attached notification letter
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-133925
- Halt date
- 2026-05-11
- Member states concerned
- Belgium
- Publication date
- 2026-05-13
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Please refer to the attached notification letter
- Follow-up measures
- Please refer to the attached notification letter
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-84362
- Halt date
- 2025-05-19
- Member states concerned
- Spain
- Publication date
- 2025-05-28
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The trial is on temporary enrolment hold as it met the criteria stated in Section 3.1.2 of clinical trial protocol version 8 dated 14-Jun-2024.
- Follow-up measures
- The ongoing patients will continue to be treated as per protocol as they are on lower dose levels. No change to the management of patients is required at this time.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-133922
- Halt date
- 2026-05-11
- Member states concerned
- Spain
- Publication date
- 2026-05-13
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Please refer to the attached notification letter
- Follow-up measures
- Please refer to the attached notification letter
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-84366
- Halt date
- 2025-05-19
- Member states concerned
- France
- Publication date
- 2025-05-28
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The trial is on temporary enrolment hold as it met the criteria stated in Section 3.1.2 of clinical trial protocol version 8 dated 14-Jun-2024.
- Follow-up measures
- The ongoing patients will continue to be treated as per protocol as they are on lower dose levels. No change to the management of patients is required at this time.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-133924
- Halt date
- 2026-05-11
- Member states concerned
- France
- Publication date
- 2026-05-13
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Please refer to the attached notification letter
- Follow-up measures
- Please refer to the attached notification letter
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-133923
- Halt date
- 2026-05-11
- Member states concerned
- Germany
- Publication date
- 2026-05-13
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Please refer to the attached notification letter
- Follow-up measures
- Please refer to the attached notification letter
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-84364
- Halt date
- 2025-05-19
- Member states concerned
- Germany
- Publication date
- 2025-05-28
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The trial is on temporary enrolment hold as it met the criteria stated in Section 3.1.2 of clinical trial protocol version 8 dated 14-Jun-2024.
- Follow-up measures
- The ongoing patients will continue to be treated as per protocol as they are on lower dose levels. No change to the management of patients is required at this time.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-84368
- Halt date
- 2025-05-19
- Member states concerned
- Belgium
- Publication date
- 2025-05-28
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The trial is on temporary enrolment hold as it met the criteria stated in Section 3.1.2 of clinical trial protocol version 8 dated 14-Jun-2024.
- Follow-up measures
- The ongoing patients will continue to be treated as per protocol as they are on lower dose levels. No change to the management of patients is required at this time.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-84370
- Halt date
- 2025-05-19
- Member states concerned
- Austria
- Publication date
- 2025-05-28
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The trial is on temporary enrolment hold as it met the criteria stated in Section 3.1.2 of clinical trial protocol version 8 dated 14-Jun-2024.
- Follow-up measures
- The ongoing patients will continue to be treated as per protocol as they are on lower dose levels. No change to the management of patients is required at this time.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-31 | Spain | Acceptable 2024-07-23
|
2024-07-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-08 | Spain | Acceptable 2025-01-14
|
2025-01-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-14 | Spain | Acceptable | 2025-04-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-14 | Acceptable | 2025-03-19 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-14 | Acceptable | 2025-03-11 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-14 | Acceptable | 2025-05-06 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-02-14 | Acceptable | 2025-04-14 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2025-02-14 | Acceptable 2025-01-14
|
2025-04-03 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-06-16 | Spain | Acceptable 2025-09-22
|
2025-09-22 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-09-30 | Acceptable | 2025-11-10 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-10-06 | Spain | Acceptable | 2025-10-28 |
| 12 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-10-13 | Acceptable | 2025-11-27 |