Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
145
Countries
5
Sites
10
Locally advanced unresectable or metastatic 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
- 21 May 2026 → ongoing
- Decision date (initial)
- 2026-02-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-521702-18-00
- WHO UTN
- U1111-1327-5353
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally advanced unresectable or metastatic colorectal cancer (CRC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10073095 | Invasive ductal breast carcinoma | 100000004864 |
| 20.0 | PT | 10075333 | Soft tissue sarcoma | 100000004864 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 20.0 | PT | 10073364 | Ductal adenocarcinoma of pancreas | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 20.0 | PT | 10073096 | Invasive lobular breast carcinoma | 100000004864 |
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 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
5 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 15 | 2 |
| France | Authorised, recruitment pending | 12 | 4 |
| Germany | Authorised, recruitment pending | 9 | 1 |
| Portugal | Authorised, recruitment pending | 8 | 1 |
| Spain | Authorised, recruitment pending | 18 | 2 |
| Rest of world
Korea, Republic of, Japan, Canada, United Kingdom, Singapore, United States, Israel
|
— | 83 | — |
Investigational sites
Odense University Hospital
1100, Onkologisk Afdeling R, J. B. Winsloews Vej 4, 5000, Odense C
Rigshospitalet
1101, Onkologisk Afd., Blegdamsvej 9, 2100, Copenhagen Oe
CHRU De Nancy
1200 Nuclear Medicine, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Oncopole Claudius Regaud
1203 Nuclear Medicine, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Paoli Calmettes
1202 Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Leon Berard
1201 Medical Oncology, 28 Rue Laennec, 69008, Lyon
Universitaetsklinikum Essen AöR
1300: Klinik für Nuklearmedizin, Hufelandstrasse 55, Holsterhausen, Essen
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
1500 : Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Hospital Universitari Vall D Hebron
1601 Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Institut Catala D'oncologia
1600 Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 |
|---|---|---|---|---|---|
| Denmark | 2026-05-21 | 2026-05-21 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-15 | Denmark | Acceptable 2026-02-16
|
2026-02-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-23 | Acceptable | 2026-03-12 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-02 | Acceptable | 2026-03-23 |