Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
329
Countries
7
Sites
15
MSIhi or dMMR advanced unresectable or metastatic solid tumors
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
- 5 Feb 2024 → ongoing
- Decision date (initial)
- 2023-09-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502314-93-00
- ClinicalTrials.gov
- NCT05838768
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
MSIhi or dMMR advanced unresectable or metastatic solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10080676 | Microsatellite instability | 10010331 |
| 20.0 | PT | 10077888 | Mismatch repair cancer syndrome | 100000004850 |
| 20.1 | PT | 10079618 | Microsatellite instability cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- 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
7 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 16 | 1 |
| France | Ongoing, recruitment ended | 40 | 3 |
| Germany | Ended | 46 | 3 |
| Italy | Ongoing, recruitment ended | 30 | 2 |
| Norway | Ongoing, recruitment ended | 12 | 1 |
| Spain | Ongoing, recruitment ended | 32 | 4 |
| Sweden | Ongoing, recruitment ended | 8 | 1 |
| Rest of world
Israel, Taiwan, Singapore, China, United States, Japan, Korea, Republic of, United Kingdom
|
— | 145 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
#1100: Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Oncopole Claudius Regaud
1204: Oncologie Médicale, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Paoli-Calmettes
1201: Oncologie Médicale, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Institut Bergonie
1200: Oncologie Médicale, 229 Cours De L Argonne, 33000, Bordeaux
Universitaetsklinikum Ulm AöR
#1302: Comprehensiv Cancer Center Ulm (CCCU) / Early Clinical Trial Unit (ECTU), Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Jena KöR
#1303: Abteilung Hämatologie und Internistische Onkologie, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Essen AöR
#1300: Innere Klinik (Tumorforschung), Hufelandstrasse 55, Holsterhausen, Essen
ASST Grande Ospedale Metropolitano Niguarda
#1500: SC. Oncologia Medica FALCK Niguarda Cancer center, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Humanitas Research Hospital
#1501: U.O. Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Oslo University Hospital HF
#1600: Department of Oncology, Montebello, Ullernchausséen 70, Oslo
Hospital Universitari Vall D Hebron
#1701: Oncologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA
#1700: Oncologia, Avenida Menendez Y Pelayo 4 Acc, 46010, Valencia
Hospital General Universitario Gregorio Maranon
#1702: Oncologia, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Fundacion Jimenez Diaz
#1703: Oncologia, Avenida De Los Reyes Catolicos 2, 28040, 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 |
|---|---|---|---|---|---|
| Belgium | 2024-09-04 | 2024-09-04 | 2026-01-26 | ||
| France | 2024-03-08 | 2024-03-08 | 2026-01-09 | ||
| Germany | 2024-02-05 | 2024-02-05 | 2025-09-11 | ||
| Italy | 2024-05-21 | 2024-05-21 | 2025-10-23 | ||
| Norway | 2024-08-01 | 2024-08-01 | 2025-08-06 | ||
| Spain | 2024-04-12 | 2024-04-12 | 2025-11-28 | ||
| Sweden | 2024-08-07 | 2024-08-07 | 2025-10-22 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-25 | France | Acceptable 2023-09-18
|
2023-09-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-24 | France | Acceptable 2024-01-10
|
2024-01-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-07 | France | Acceptable 2024-10-07
|
2024-10-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-31 | France | Acceptable 2025-04-02
|
2025-04-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-11 | France | Acceptable | 2025-05-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-11 | France | Acceptable 2025-08-07
|
2025-08-07 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-09 | France | Acceptable 2026-03-11
|
2026-03-11 |