Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
120
Countries
2
Sites
8
Stage IIB/C, Stage III, or Stage IV Melanoma
Key facts
- Sponsor
- Biocon Biologics UK PLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-06-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-525158-20-00
- ClinicalTrials.gov
- NCT07476326
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Stage IIB/C, Stage III, or Stage IV Melanoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Biocon Biologics UK PLC
- Sponsor organisation
- Biocon Biologics UK PLC
- Address
- Covent Garden, 16 Great Queen Street 16 Great Queen Street
- City
- London
- Postcode
- WC2B 5AH
- Country
- United Kingdom
Scientific contact point
- Organisation
- Biocon Biologics UK PLC
- Contact name
- Dr. Dharma Rao Uppada, MD
Public contact point
- Organisation
- Biocon Biologics UK PLC
- Contact name
- Rajesh CN
Locations
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Authorised, recruitment pending | 15 | 1 |
| Spain | Authorised, recruitment pending | 28 | 7 |
| Rest of world
Serbia, Brazil, Turkey, Georgia, South Africa
|
— | 77 | — |
Investigational sites
Centrul De Oncologie SF Nectarie S.R.L.
Medical Oncology, Strada Caracal Nr 109, 200542, Craiova
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Clinical Hospital Virgen De La Arrixaca
Oncology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Instituto Oncologico Dr. Rosell S.L.
Oncology, Calle De Sabino Arana Num. 5, 08028, Barcelona
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1, 08208, Sabadell
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-07 | Spain | Acceptable 2026-06-17
|
2026-06-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-07-01 | Spain | Acceptable 2026-06-17
|
2026-07-01 |