Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
100
Countries
3
Sites
11
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
- 27 Jan 2026 → ongoing
- Decision date (initial)
- 2025-11-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-521828-30-00
- ClinicalTrials.gov
- NCT06795412
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
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 9 | 5 |
| Poland | Ended | 2 | 1 |
| Spain | Ongoing, recruiting | 10 | 5 |
| Rest of world
United States
|
— | 79 | — |
Investigational sites
Centre Hospitalier Universitaire De Bordeaux
Medical Oncology, 1 Rue Jean Burguet, 33000, Bordeaux
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Hospitalier Regional De Marseille
Centre d’Essais Précoces en Cancérologie de Marseille (CEPCM), 264 Rue Saint Pierre, 13005, Marseille
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Medical Oncologist, 114 Rue Edouard Vaillant, 94800, Villejuif
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddział w Gliwicach; Centrum Wsparcia Badań Klinicznych, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Hospital Universitario 12 De Octubre
Oncology department, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitari Vall D Hebron
Oncology department, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
Oncology department, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Clinico Universitario De Valencia
Oncology department, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Oncology department, Avenida De Los Reyes Catolicos 2, 28040, 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 | 2026-02-19 | 2026-05-04 | |||
| Spain | 2026-01-27 | 2026-04-09 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-30 | Spain | Acceptable 2025-11-18
|
2025-11-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-11 | Spain | Acceptable 2025-11-18
|
2025-12-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-05 | Spain | Acceptable 2026-04-17
|
2026-04-17 |