Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
290
Countries
2
Sites
4
Gastrointestinal stromal tumor
Key facts
- Sponsor
- Ningbo Newbay Technology Development Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Oct 2023 → 1 Aug 2025
- Decision date (initial)
- 2023-06-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502401-15-00
- ClinicalTrials.gov
- NCT04936178
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Gastrointestinal stromal tumor
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 21.1 | LLT | 10053571 | Melanoma | 10029104 |
| 21.1 | PT | 10051066 | Gastrointestinal stromal tumour | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ningbo Newbay Technology Development Co. Ltd.
- Sponsor organisation
- Ningbo Newbay Technology Development Co. Ltd.
- Address
- Building No.1 Room 301, 39 Qiyuan Road, Hangzhouwan New Zone 39 Qiyuan Road Hangzhouwan New Zone
- City
- Ningbo
- Postcode
- 315336
- Country
- China
Scientific contact point
- Organisation
- Ningbo Newbay Technology Development Co. Ltd.
- Contact name
- Clinical Trial information desk
Public contact point
- Organisation
- Ningbo Newbay Technology Development Co. Ltd.
- Contact name
- Clinical Trial information desk
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 15 | 2 |
| Spain | Ended | 22 | 2 |
| Rest of world
United States, United Kingdom, Korea, Republic of, China
|
— | 253 | — |
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 |
|---|---|---|---|---|---|
| France | 2023-10-19 | 2023-11-08 | 2025-01-02 | ||
| Spain | 2023-12-11 | 2023-12-12 | 2025-01-02 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-01 | Spain | Acceptable with conditions 2023-06-19
|
2023-06-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-07-05 | Spain | Acceptable with conditions 2023-06-19
|
2023-07-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-10 | Spain | Acceptable 2023-09-04
|
2023-09-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-03 | Spain | Acceptable 2024-03-25
|
2024-03-25 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-04 | Spain | Acceptable 2024-09-13
|
2024-09-13 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-13 | Spain | Acceptable 2024-09-13
|
2024-12-13 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-01-28 | Spain | Acceptable | 2025-02-05 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-06-13 | Spain | Acceptable 2025-07-28
|
2025-07-29 |