Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
130
Countries
3
Sites
14
Advanced Solid Tumors
Key facts
- Sponsor
- Ideaya Biosciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Mar 2023 → ongoing
- Decision date (initial)
- 2024-03-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-510995-18-00
- EudraCT number
- 2022-002607-37
- ClinicalTrials.gov
- NCT04794699
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ideaya Biosciences Inc.
- Sponsor organisation
- Ideaya Biosciences Inc.
- Address
- 7000 Shoreline Court Suite 350
- City
- South San Francisco
- Postcode
- 94080-7604
- Country
- United States
Scientific contact point
- Organisation
- Ideaya Biosciences Inc.
- Contact name
- Ideaya Scientific contact point
Public contact point
- Organisation
- Ideaya Biosciences Inc.
- Contact name
- Ideaya Public contact point
Locations
3 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 15 | 6 |
| Germany | Ended | 15 | 1 |
| Spain | Ongoing, recruitment ended | 15 | 7 |
| Rest of world
United States, Taiwan, Australia, Korea, Republic of
|
— | 85 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
Oncologie Médicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Regional De Marseille
CEPCM, 264 Rue Saint Pierre, 13005, Marseille
Institut Bergonié
Oncologie Médicale, 229 cours de l'Argonne, 33076, Bordeaux
Centre Eugène Marquis
Oncologie médicale, Avenue de la Bataille de Flandres Dunkerque, 35000, Rennes
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
University Medical Center Hamburg-Eppendorf
Dept. Medicine II, Martinistrasse 52, Eppendorf, Hamburg
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Quironsalud Madrid
Medical Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Quironsalud Barcelona
Medical Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Fundacion Instituto Valenciano De Oncologia
Medical Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
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 | 2023-03-01 | 2023-03-21 | 2026-03-10 | ||
| Germany | 2024-01-22 | ||||
| Spain | 2023-07-04 | 2023-07-24 | 2026-03-10 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-DE-0001
- Member state
- Germany
- Publication date
- 2024-07-16
- Type
- 4
- Reason
- 7
- Immediate action required
- No
- Justification
- ASR-2024-00315, DE-0000000054. See proposed CM.
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-15 | Germany | Acceptable 2024-03-20
|
2024-03-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-17 | Germany | Acceptable 2024-07-29
|
2024-07-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-23 | Germany | Acceptable 2024-11-08
|
2024-11-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-18 | Germany | Acceptable 2025-03-25
|
2025-03-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-30 | Germany | Acceptable 2025-09-22
|
2025-09-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-27 | Germany | Acceptable 2026-02-02
|
2026-02-02 |