Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
123
Countries
1
Sites
6
Locally Advanced or Metastatic Solid Tumors with EGFR and/or HER2 Aberrations
Key facts
- Sponsor
- Taiho Oncology Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Jan 2022 → 25 Mar 2025
- Decision date (initial)
- 2023-10-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506922-35-00
- EudraCT number
- 2021-002189-41
- ClinicalTrials.gov
- NCT04982926
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally Advanced or Metastatic Solid Tumors with EGFR and/or HER2 Aberrations
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065143 | Malignant solid tumour | 10029104 |
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Taiho Oncology Inc.
- Sponsor organisation
- Taiho Oncology Inc.
- Address
- 101 Carnegie Center Suite 101
- City
- Princeton
- Postcode
- 08540-6231
- Country
- United States
Scientific contact point
- Organisation
- Taiho Oncology Inc.
- Contact name
- Medical Monitor
Public contact point
- Organisation
- Taiho Oncology Inc.
- Contact name
- Medical Monitor
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 23 | 6 |
| Rest of world
United States
|
— | 100 | — |
Investigational sites
Institut Gustave Roussy
Département d'Innovation Thérapeutique et des Essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Hospices Civils De Lyon
Pneumologie, 59 Boulevard Pinel, 69500, Bron
Institut Bergonie
Oncologie Médicale, 229 Cours De L Argonne, 33000, Bordeaux
Institut Claudius Regaud / Oncopole / CHU Toulouse
Pneumologie, 1 Avenue Irène Joliot Curie, 31059, TOULOUSE
Hôpital La Timone - APHM
Oncologie multidisciplinaire et innovations thérapeutiques, 264 Rue Saint-Pierre, 13005, Marseille
Institut de Cancérologie de l'Ouest - site de Saint Herblain
Oncologie Médicale, Boulevard Jacques Monod, 44805, SAINT HERBLAIN
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 | 2022-01-24 | 2022-01-24 | 2024-05-30 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-11 | France | Acceptable 2023-09-27
|
2023-10-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-25 | France | Acceptable 2023-09-27
|
2024-01-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-14 | France | Acceptable | 2024-04-02 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-02-16 | France | Acceptable | 2024-02-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-02-22 | France | Acceptable | 2024-04-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-04-15 | France | Acceptable | 2024-05-17 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-03 | France | Acceptable | 2024-12-03 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-12-04 | France | Acceptable | 2024-12-04 |