Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
124
Countries
6
Sites
16
Locally advanced or metastatic unresectable colorectal cancer (CRC)
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Jul 2025 → ongoing
- Decision date (initial)
- 2024-12-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510356-23-00
- WHO UTN
- U1111-1325-8631
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally advanced or metastatic unresectable colorectal cancer (CRC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10073096 | Invasive lobular breast carcinoma | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 20.0 | PT | 10073095 | Invasive ductal breast carcinoma | 100000004864 |
| 20.0 | PT | 10073364 | Ductal adenocarcinoma of pancreas | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
6 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 7 | 1 |
| France | Ongoing, recruiting | 9 | 4 |
| Germany | Ongoing, recruiting | 23 | 4 |
| Italy | Ongoing, recruiting | 7 | 2 |
| Netherlands | Ongoing, recruiting | 9 | 2 |
| Spain | Ongoing, recruiting | 21 | 3 |
| Rest of world
Israel, Japan, Canada, Switzerland, United States
|
— | 48 | — |
Investigational sites
Institut Jules Bordet
1001:Nucleair Medicine, Mijlenmeersstraat 90, 1070, Anderlecht
Institut Gustave Roussy
1101: Medecine Nucleaire, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospices Civils De Lyon
1102: Medecine Nucleaire, 5 Place D Arsonval, 69437, Lyon Cedex 03
Hospices Civils De Lyon
1102: Medecine Nucleaire, 59 Boulevard Pinel, 69500, Bron
Hospices Civils De Lyon
1102: Medecine Nucleaire, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Rostock University Medical Center
1204: Klinik und Poliklinik für Nuklearmedizin, Gertrudenplatz 1, Kroepeliner Tor Vorstadt, Rostock
University Hospital Cologne AöR
1203: Klinik und Poliklinik für Nuklearmedizin, Kerpener Strasse 62, Lindenthal, Cologne
Klinikum rechts der Isar der TU Muenchen AöR
1202: Klinik und Poliklinik für Nuklearmedizin, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Essen AöR
1201: Klinik für Nuklearmedizin, Hufelandstrasse 55, Holsterhausen, Essen
Azienda USL IRCCS Di Reggio Emilia
1402: S.C. Medicina Nucleare, Viale Risorgimento 80, 42123, Reggio Emilia
Fondazione IRCCS Istituto Nazionale Dei Tumori
1401: SC Medicina Nucleare, Via Giacomo Venezian 1, 20133, Milan
Radboud universitair medisch centrum / RADBOUDUMC
1501 :Medische Beeldvorming, sectie Nucleaire Geneeskunde, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Universitair Medisch Centrum Utrecht
1502 :Medische Oncologie, Heidelberglaan 100, 3584 CX, Utrecht
Hospital General Universitario Gregorio Maranon
1602 :Oncología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Fundacion Jimenez Diaz
1603 :Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinic De Barcelona
1601 :Oncología, Calle Villarroel 170, 08036, Barcelona
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 | 2026-05-12 | 2026-05-12 | |||
| France | 2025-07-29 | 2025-07-29 | |||
| Germany | 2026-05-13 | 2026-05-13 | |||
| Italy | 2026-05-15 | 2026-05-15 | |||
| Netherlands | 2026-05-22 | 2026-05-22 | |||
| Spain | 2025-07-18 | 2025-07-18 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-21 | Spain | Acceptable 2024-12-04
|
2024-12-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-17 | Spain | Acceptable 2024-12-04
|
2024-12-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-20 | Spain | Acceptable 2025-06-12
|
2025-06-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-21 | Spain | Acceptable 2025-12-01
|
2025-12-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-05 | Spain | Acceptable 2026-04-13
|
2026-04-14 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-04-30 | Acceptable | 2026-05-12 |