Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
135
Countries
2
Sites
8
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
- 2 Aug 2023 → 10 Mar 2026
- Decision date (initial)
- 2023-07-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502891-22-00
- WHO UTN
- U1111-1285-3903
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
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 39 | 3 |
| Spain | Ended | 57 | 5 |
| Rest of world
United States
|
— | 39 | — |
Investigational sites
Centro Ricerche Cliniche Di Verona S.r.l.
UOC Oncologia - AOUI Verona, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Fase 1, Largo Francesco Vito 1, 00168, Rome
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Sperimentazioni Cliniche, Via Mariano Semmola 52, 80131, Naples
University Clinic Of Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
University Clinic Of Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, 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 |
|---|---|---|---|---|---|
| Italy | 2023-10-09 | 2023-11-24 | 2024-09-24 | ||
| Spain | 2023-08-02 | 2023-08-11 | 2024-09-24 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-107431
- 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
Temporary halt TH-107430
- Halt date
- 2025-11-05
- Member states concerned
- Italy
- Publication date
- 2025-11-20
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-21 | Spain | Acceptable 2023-06-30
|
2023-07-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-18 | Spain | Acceptable 2023-11-28
|
2023-11-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-12-20 | Spain | Acceptable 2023-11-28
|
2023-12-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-18 | Spain | Acceptable 2024-06-03
|
2024-06-03 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-07-19 | Spain | Acceptable 2024-06-03
|
2024-07-19 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-03-05 | Spain | Acceptable 2024-06-03
|
2025-03-05 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-20 | Spain | Acceptable | 2025-03-27 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-07-24 | Spain | Acceptable | 2025-07-24 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-09-09 | Spain | Acceptable | 2025-09-09 |