Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
158
Countries
1
Sites
3
Advanced or Metastatic Hepatocellular Carcinoma
Key facts
- Sponsor
- Alnylam Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Aug 2025 → ongoing
- Decision date (initial)
- 2025-06-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519499-22-00
- ClinicalTrials.gov
- NCT06600321
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or Metastatic Hepatocellular Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10073071 | Hepatocellular carcinoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Alnylam Pharmaceuticals Inc.
- Sponsor organisation
- Alnylam Pharmaceuticals Inc.
- Address
- 300 3rd Street
- City
- Cambridge
- Postcode
- 02142-1103
- Country
- United States
Scientific contact point
- Organisation
- Alnylam Pharmaceuticals Inc.
- Contact name
- Alnylam Clincial Trial Information Line
Public contact point
- Organisation
- Alnylam Pharmaceuticals Inc.
- Contact name
- Alnylam Clincial Trial Information Line
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 31 | 3 |
| Rest of world
United States, Korea, Republic of
|
— | 127 | — |
Investigational sites
Centro Ricerche Cliniche Di Verona S.r.l.
Oncology Unit, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Humanitas Mirasole S.p.A.
Operative unit of Oncology and Hematology, Via Alessandro Manzoni 56, 20089, Rozzano
Ospedale San Raffaele S.r.l.
U.O. Oncologia Medica unità di Fase I, 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 |
|---|---|---|---|---|---|
| Italy | 2025-08-04 | 2025-10-29 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-28 | Italy | Acceptable 2025-06-18
|
2025-06-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-19 | Italy | Acceptable 2026-01-08
|
2026-01-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-12 | Italy | Acceptable 2026-04-07
|
2026-04-28 |