Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
350
Countries
2
Sites
9
Advanced 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
- 29 Aug 2024 → ongoing
- Decision date (initial)
- 2023-12-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509687-14-00
- EudraCT number
- 2022-002284-30
- ClinicalTrials.gov
- NCT05720117
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced 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 | Ongoing, recruiting | 10 | 4 |
| Spain | Ongoing, recruiting | 80 | 5 |
| Rest of world
United States, United Kingdom
|
— | 260 | — |
Investigational sites
Universitair Ziekenhuis Gent
Drug Research Unit, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Institut Jules Bordet
Clinical Trial Conduct Unit, Mijlenmeersstraat 90, 1070, Anderlecht
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Oncology, Avenida Menendez Y Pelayo 4, 46010, Valencia
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, 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 | 2023-06-26 | 2023-08-08 | |||
| Spain | 2023-08-24 | 2023-12-20 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-41252
- Halt date
- 2024-08-03
- Planned restart
- 2024-09-16
- Member states concerned
- Spain
- Publication date
- 2024-08-16
- Reason
- Study management related
- Explanation
- Enrollment has been placed on temporary halt due to pending regulatory approval of protocol amendment for increase in sample size from 45 to approximately 80 subjects. At the time of the amendment submission on 17 June 2024, the number of participants enrolled had surpassed 45 (50 enrolled globally).
- Follow-up measures
- No additional follow-up measures. Currently enrolled subjects continue participation in the study as per approved protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-41251
- Halt date
- 2024-08-03
- Planned restart
- 2024-09-16
- Member states concerned
- Belgium
- Publication date
- 2024-08-16
- Reason
- Study management related
- Explanation
- Enrollment has been placed on temporary halt due to pending regulatory approval of protocol amendment for increase in sample size from 45 to approximately 80 subjects. At the time of the amendment submission on 17 June 2024, the number of participants enrolled had surpassed 45 (50 enrolled globally).
- Follow-up measures
- No additional follow-up measures. Currently enrolled subjects continue participation in the study as per approved protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-07 | Belgium | Acceptable 2023-12-21
|
2023-12-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-17 | Belgium | Acceptable with conditions 2024-08-28
|
2024-08-28 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-20 | Belgium | Acceptable with conditions 2024-08-28
|
2024-09-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-10 | Belgium | Acceptable 2025-03-21
|
2025-03-21 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-11 | Belgium | Acceptable 2025-03-21
|
2025-04-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-16 | Belgium | Acceptable 2025-05-27
|
2025-05-27 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-16 | Belgium | Acceptable 2025-05-27
|
2025-06-16 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-16 | Belgium | Acceptable 2025-11-25
|
2025-11-26 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-26 | Belgium | Acceptable with conditions 2026-05-06
|
2026-05-06 |