Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
149
Countries
2
Sites
5
Adult patients with advanced or metastatic solid malignancies with radiologically documented progression on a previous line of treatment and for which effective treatment options do not exist.
Key facts
- Sponsor
- Phost'In Therapeutics
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516574-30-00
- EudraCT number
- 2021-004170-55
- ClinicalTrials.gov
- NCT05495295
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Adult patients with advanced or metastatic solid malignancies with radiologically documented progression on a previous line of treatment and for which effective treatment options do not exist.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Phost'In Therapeutics
- Sponsor organisation
- Phost'In Therapeutics
- Address
- 104 Rue De La Galera
- City
- Montpellier
- Postcode
- 34090
- Country
- France
Scientific contact point
- Organisation
- Phost'In Therapeutics
- Contact name
- CEO/President
Public contact point
- Organisation
- Phost'In Therapeutics
- Contact name
- CEO/President
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 40 | 2 |
| Italy | Ongoing, recruitment ended | 109 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Regional Du Cancer De Montpellier
Early Clinical Trial Unit - Medical Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut Paoli Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Azienda USL IRCCS Di Reggio Emilia
Medical Oncology, Viale Risorgimento 80, 42123, Reggio Emilia
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology I, Via Giacomo Venezian 1, 20133, Milan
Ospedale San Raffaele S.r.l.
Medical Oncology - Phase 1 Unit, Via Olgettina 60, 20132, Milan
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 | 2024-10-17 | 2024-10-17 | 2026-02-11 | ||
| Italy | 2024-10-15 | 2024-10-15 | 2026-02-11 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-06 | France | Acceptable 2024-10-04
|
2024-10-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-31 | France | Acceptable 2025-03-12
|
2025-03-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-02 | France | Acceptable 2025-05-16
|
2025-05-16 |