Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
60
Countries
2
Sites
9
Solid Tumors
Key facts
- Sponsor
- Pyxis Oncology Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Jul 2023 → 23 Feb 2026
- Decision date (initial)
- 2024-01-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509686-21-00
- EudraCT number
- 2022-002306-24
- ClinicalTrials.gov
- NCT05718557
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
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
Pyxis Oncology Inc.
- Sponsor organisation
- Pyxis Oncology Inc.
- Address
- 321 Harrison Avenue
- City
- Boston
- Postcode
- 02118-2659
- Country
- United States
Scientific contact point
- Organisation
- Pyxis Oncology Inc.
- Contact name
- Clinical Trial Manager
Public contact point
- Organisation
- Pyxis Oncology Inc.
- Contact name
- Clinical Trial Manager
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 12 | 4 |
| Spain | Ended | 15 | 5 |
| Rest of world
United States
|
— | 33 | — |
Investigational sites
Grand Hopital De Charleroi
Medical Ongocology, Grand'rue 3, 6000, Charleroi
UZ Leuven
Hepatology, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Geneesmiddelen-onderzoek, Corneel Heymanslaan 10, 9000, Gent
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Dexeus Grupo Quironsalud
Medical Oncology Service, Calle De Sabino Arana 5-19, 08028, 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 |
|---|---|---|---|---|---|
| Belgium | 2023-07-05 | 2025-05-26 | 2023-11-07 | 2024-12-18 | |
| Spain | 2023-08-04 | 2025-05-26 | 2023-12-18 | 2024-12-18 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-12 | Belgium | Acceptable 2024-01-10
|
2024-01-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-15 | Belgium | Acceptable 2024-06-18
|
2024-06-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-27 | Belgium | Acceptable 2024-07-23
|
2024-07-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-07 | Acceptable | 2024-09-04 |