Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
104
Countries
2
Sites
5
esophageal, gastric, or gastroesophageal junction adenocarcinoma
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
- 3 Mar 2025 → 28 Jan 2026
- Decision date (initial)
- 2025-01-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512380-32-00
- ClinicalTrials.gov
- NCT06560645
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
esophageal, gastric, or gastroesophageal junction adenocarcinoma
| 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
- 175 Innovation Boulevard
- City
- Wilmington
- Postcode
- 19805
- 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
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 10 | 2 |
| Spain | Ended | 6 | 3 |
| Rest of world
Japan, Australia, Korea, Republic of, United States
|
— | 88 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Germany | 2025-03-28 | 2025-06-12 | 2025-11-04 | ||
| Spain | 2025-03-03 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-20 | Germany | Acceptable 2025-01-17
|
2025-01-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-06 | Acceptable | 2025-03-14 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-06 | Germany | Acceptable | 2025-02-28 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-29 | Germany | Acceptable | 2025-07-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-12 | Germany | Acceptable 2025-10-06
|
2025-10-07 |