Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
40
Countries
3
Sites
12
Advanced Melanoma
Key facts
- Sponsor
- Microbiotica Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Aug 2024 → ongoing
- Decision date (initial)
- 2024-07-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507377-17-00
- WHO UTN
- U1111-1304-8178
- ClinicalTrials.gov
- NCT06540391
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10025650 | Malignant melanoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Microbiotica Limited
- Sponsor organisation
- Microbiotica Limited
- Address
- The Newham Building, Chesterford Park, Little Chesterford Chesterford Park Little Chesterford
- City
- Saffron Walden
- Postcode
- CB10 1XL
- Country
- United Kingdom
Scientific contact point
- Organisation
- Microbiotica Limited
- Contact name
- Microbiotica Information
Public contact point
- Organisation
- Microbiotica Limited
- Contact name
- Microbiotica Information
Locations
3 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 11 | 5 |
| Italy | Ongoing, recruitment ended | 7 | 3 |
| Spain | Ongoing, recruitment ended | 9 | 4 |
| Rest of world
United Kingdom
|
— | 13 | — |
Investigational sites
Centre Hospitalier Regional De Marseille
Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM-CLIPP), 264 Rue Saint Pierre, 13005, Marseille
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier Universitaire De Lille
Service de Dermatologie, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Hospices Civils De Lyon
Dermatology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Melanoma. Cancer Immunotherapy and Development Therapeutics Unit, Via Mariano Semmola 52, 80131, Naples
Istituto Europeo Di Oncologia S.r.l.
Divisione di Sviluppo di nuovi farmaci per terapie innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Humanitas Mirasole S.p.A.
Operative Unit of Oncology and Hematology, Via Alessandro Manzoni 56, 20089, Rozzano
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital General Universitario De Valencia
Oncology, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, 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 | 2024-10-09 | 2024-11-21 | 2025-08-28 | ||
| Italy | 2024-08-28 | 2024-08-28 | 2025-08-28 | ||
| Spain | 2024-09-06 | 2024-10-03 | 2025-08-28 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-28 | France | Acceptable 2024-07-22
|
2024-07-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-30 | France | Acceptable 2024-07-22
|
2024-07-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-30 | Acceptable 2024-07-22
|
2024-07-30 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-31 | France | Acceptable | 2024-09-09 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-19 | France | Acceptable 2025-01-17
|
2025-01-17 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-22 | France | Acceptable 2025-01-17
|
2025-01-22 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-20 | France | Acceptable 2025-05-05
|
2025-05-05 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-08-06 | France | Acceptable 2025-05-05
|
2025-08-06 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-16 | France | Acceptable 2026-03-13
|
2026-03-13 |