Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
376
Countries
1
Sites
3
Advanced Solid Tumors
Key facts
- Sponsor
- Hifibio Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Jun 2022 → 10 Mar 2026
- Decision date (initial)
- 2024-04-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511286-11-00
- EudraCT number
- 2021-006231-25
- WHO UTN
- U1111-1303-8965
- ClinicalTrials.gov
- NCT05238883
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hifibio Inc.
- Sponsor organisation
- Hifibio Inc.
- Address
- 237 Putnam Avenue
- City
- Cambridge
- Postcode
- 02139-3807
- Country
- United States
Scientific contact point
- Organisation
- Hifibio Inc.
- Contact name
- Regulatory Submissions
Public contact point
- Organisation
- Hifibio Inc.
- Contact name
- Hifibio Clinical
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 188 | 3 |
| Rest of world
United States, China
|
— | 188 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Spain | 2022-06-03 | 2022-06-16 | 2024-09-24 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-107344
- Halt date
- 2025-11-05
- Member states concerned
- Spain
- Publication date
- 2025-11-20
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-15 | Spain | Acceptable 2024-04-22
|
2024-04-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-04 | Spain | Acceptable 2024-04-22
|
2024-10-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-08 | Spain | Acceptable | 2024-11-08 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-20 | Spain | Acceptable | 2024-12-20 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-24 | Spain | Acceptable | 2025-07-24 |