Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
1,115
Countries
3
Sites
10
Advanced solid tumor with a PIK3CA mutation in blood and/or tumor per local assessment.
Key facts
- Sponsor
- Relay Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Oct 2022 → ongoing
- Decision date (initial)
- 2022-12-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-500264-35-00
- WHO UTN
- U1111-1276-5380
- ClinicalTrials.gov
- NCT05216432
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumor with a PIK3CA mutation in blood and/or tumor per local assessment.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10006290 | Breast and nipple neoplasms malignant | 10029104 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Relay Therapeutics Inc.
- Sponsor organisation
- Relay Therapeutics Inc.
- Address
- 60 Hampshire Street
- City
- Cambridge
- Postcode
- 02139-1548
- Country
- United States
Scientific contact point
- Organisation
- Relay Therapeutics Inc.
- Contact name
- Clinical Operations
Public contact point
- Organisation
- Relay Therapeutics Inc.
- Contact name
- Regulatory Submissions
Locations
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 84 | 3 |
| Italy | Ongoing, recruiting | 53 | 1 |
| Spain | Ongoing, recruiting | 168 | 6 |
| Rest of world
United States, Australia
|
— | 810 | — |
Investigational sites
Centre Leon Berard
Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Catalan Institute Of Oncology
Oncology, Carretera Canyet S/n, 08916, Badalona
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Vall D Hebron Institute Of Oncology
Oncología, Calle Natzaret 115, 08035, Barcelona
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 | 2023-10-04 | 2023-10-30 | |||
| Italy | 2023-07-25 | 2023-08-22 | |||
| Spain | 2022-10-28 | 2022-10-31 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-04-28 | Spain | Acceptable 2022-08-16
|
2022-08-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-4 | 2022-11-10 | Spain | Acceptable with conditions | 2022-11-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-5 | 2022-11-15 | Spain | Acceptable with conditions | 2022-12-02 |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2022-11-21 | Acceptable with conditions | 2022-12-20 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-7 | 2022-12-20 | Spain | Acceptable 2023-02-13
|
2023-02-14 |
| 6 | SUBSTANTIAL MODIFICATION | SM-8 | 2023-04-17 | Spain | Acceptable 2023-07-03
|
2023-07-03 |
| 7 | SUBSTANTIAL MODIFICATION | SM-9 | 2023-10-27 | Spain | Acceptable 2024-02-05
|
2024-02-05 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-02-14 | Acceptable 2024-02-05
|
2024-02-14 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-03-13 | Spain | Acceptable 2024-05-09
|
2024-05-09 |
| 10 | SUBSTANTIAL MODIFICATION | SM-12 | 2024-08-08 | Spain | Acceptable 2024-10-03
|
2024-10-03 |
| 11 | SUBSTANTIAL MODIFICATION | SM-13 | 2024-11-29 | Spain | Acceptable with conditions 2025-03-03
|
2025-03-05 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-03-10 | Acceptable with conditions 2025-03-03
|
2025-03-10 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-03-26 | Spain | Acceptable with conditions 2025-03-03
|
2025-03-26 |
| 14 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-06-25 | Spain | Acceptable 2025-09-15
|
2025-09-15 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-09-29 | Spain | Acceptable 2025-09-15
|
2025-09-29 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-10-21 | Acceptable 2025-09-15
|
2025-10-21 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-11-27 | Spain | Acceptable 2026-02-26
|
2026-02-27 |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-03-03 | Spain | Acceptable 2026-02-26
|
2026-03-03 |
| 19 | SUBSTANTIAL MODIFICATION | SM-16 | 2026-03-09 | Acceptable | 2026-03-18 |