Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
250
Countries
1
Sites
1
Advanced Cancer
Key facts
- Sponsor
- Torl Biotherapeutics LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-07-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517189-40-00
- ClinicalTrials.gov
- NCT05103683
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Torl Biotherapeutics LLC
2
Total trials
Commercial
- Sponsor organisation
- Torl Biotherapeutics LLC
- Address
- 6100 Bristol Parkway
- City
- Culver City
- Postcode
- 90230-6604
- Country
- United States
Scientific contact point
- Organisation
- Torl Biotherapeutics LLC
- Contact name
- TORL Clinical Trial Information
Public contact point
- Organisation
- Torl Biotherapeutics LLC
- Contact name
- TORL Clinical Trial Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Ireland | Authorised, recruitment pending | 12 | 1 |
| Rest of world
United States, Korea, Republic of
|
— | 238 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-30 | Ireland | Acceptable 2026-06-19
|
2026-07-06 |