Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
231
Countries
4
Sites
11
gastroesophageal junction
Key facts
- Sponsor
- Prelude Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Sep 2023 → 2 Oct 2025
- Decision date (initial)
- 2023-08-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502850-14-00
- ClinicalTrials.gov
- NCT05639751
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
gastroesophageal junction
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Prelude Therapeutics Inc.
- Sponsor organisation
- Prelude Therapeutics Inc.
- Address
- 200 Powder Mill Road
- City
- Wilmington
- Postcode
- 19803-2907
- Country
- United States
Scientific contact point
- Organisation
- Prelude Therapeutics Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Prelude Therapeutics Inc.
- Contact name
- General Contact
Locations
4 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 40 | 5 |
| Germany | Ended | 5 | 1 |
| Netherlands | Ended | 5 | 1 |
| Spain | Ended | 20 | 4 |
| Rest of world
United States, Singapore
|
— | 161 | — |
Investigational sites
Oncopole Claudius Regaud
Early Phase Unit, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Bergonie
Medical Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Institut Paoli Calmettes
Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Department of Oncology Medicine, 114 Rue Edouard Vaillant, 94800, Villejuif
Technische Universitaet Dresden
Medizinische Fakultät Carl Gustav Carus, NCT/UCC ECTU, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Leiden University Medical Center
Pulmonary Diseases, Albinusdreef 2, 2333 ZA, Leiden
Hospital Universitario Fundacion Jimenez Diaz
oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Hm Nou Delfos
Medical Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Hm Sanchinarro
oncology, Calle Ona 10, 28050, 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 |
|---|---|---|---|---|---|
| France | 2024-01-26 | 2025-09-18 | 2024-02-14 | 2025-06-16 | |
| Netherlands | 2024-03-07 | 2025-07-01 | 2024-06-06 | 2025-06-16 | |
| Spain | 2023-09-25 | 2025-10-01 | 2023-11-29 | 2025-06-16 |
Application history
16 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-10 | Spain | Acceptable 2023-08-21
|
2023-08-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-09-12 | Acceptable | 2023-10-23 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-09-13 | Spain | Acceptable | 2023-09-29 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2023-11-08 | Acceptable 2023-08-21
|
2024-01-02 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-02-23 | Spain | Acceptable 2024-05-10
|
2024-05-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-06-14 | Spain | Acceptable 2024-09-09
|
2024-09-09 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-16 | Spain | Acceptable 2024-09-09
|
2024-09-16 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-30 | Spain | Acceptable 2024-09-09
|
2024-09-30 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-09-30 | Acceptable 2024-09-09
|
2024-09-30 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-10-01 | Acceptable 2024-09-09
|
2024-10-01 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-10-07 | Acceptable 2024-09-09
|
2024-10-07 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-10-07 | 2024-11-25 | ||
| 13 | SUBSEQUENT ADDITION OF MSC | APP-13 | 2024-10-30 | 2025-02-07 | ||
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-02-26 | 2025-02-26 | ||
| 15 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-03-18 | Spain | Acceptable with conditions 2025-06-19
|
2025-06-19 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-07-29 | Spain | Acceptable with conditions 2025-06-19
|
2025-07-29 |