Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
114
Countries
3
Sites
25
HER2-positive advanced solid tumours
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 May 2024 → ongoing
- Decision date (initial)
- 2024-04-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508459-37-00
- ClinicalTrials.gov
- NCT05593094
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
HER2-positive advanced solid tumours
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10072740 | Locally advanced breast cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information Support Line-TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Head of EU
Locations
3 EU/EEA countries · 25 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 15 | 7 |
| Italy | Ongoing, recruitment ended | 5 | 5 |
| Spain | Ongoing, recruitment ended | 14 | 13 |
| Rest of world
United Kingdom, Australia, New Zealand, United States
|
— | 80 | — |
Investigational sites
Institut Paoli-Calmettes
N/A, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centr Georges Francois Leclerc
N/A, 1 Rue Professeur Marion, 21000, Dijon
Centre Leon Berard
N/A, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
N/A, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Oscar Lambret
N/A, 3 Rue Frederic Combemale, 59000, Lille
Institut Universitaire Du Cancer Toulouse-Oncopole
N/A, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut De Cancerologie De L Ouest
N/A, Bd Du Professeur Jacques Monod, 44800, St Herblain
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Struttura Complessa di Oncologia, Piazza Oms 1, 24127, Bergamo
Fondazione IRCCS San Gerardo Dei Tintori
Centro Ricerca Fase 1, Via Giovanni Battista Pergolesi 33, 20900, Monza
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase 1 Unit, Largo Francesco Vito 1, 00168, Rome
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Struttura Complessa di Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Istituto Europeo Di Oncologia S.r.l.
New Drug Development for Innovative Therapies (Sviluppo di Nuovi Farmaci per Terapie Innovative), Via Giuseppe Ripamonti 435, 20141, Milan
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Dexeus Grupo Quironsalud
Medical Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Fundacion Instituto Valenciano De Oncologia
Medical Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario De Jaen
Medical Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Beata Maria Ana
Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Complexo Hospitalario Universitario De Santiago
Medical Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
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 |
|---|---|---|---|---|---|
| France | 2024-06-13 | 2024-09-05 | 2025-07-30 | ||
| Italy | 2025-07-02 | 2025-07-28 | 2025-07-30 | ||
| Spain | 2024-05-28 | 2024-06-26 | 2025-07-08 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-15 | France | Acceptable 2024-04-22
|
2024-04-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-25 | France | Acceptable 2024-09-03
|
2024-09-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-18 | France | Acceptable 2024-09-03
|
2024-11-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-25 | Acceptable | 2024-12-05 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-02-24 | 2025-05-21 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-27 | France | Acceptable 2025-09-12
|
2025-09-12 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-09 | France | Acceptable 2025-10-24
|
2025-10-24 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-04 | France | Acceptable 2025-11-26
|
2025-11-26 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-08 | France | Acceptable 2025-11-26
|
2025-12-08 |