Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
134
Countries
4
Sites
15
Advanced solid tumors, Breast Cancer
Key facts
- Sponsor
- Atavistik Bio Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Oct 2025 → 17 Apr 2026
- Decision date (initial)
- 2025-09-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521480-12-00
- WHO UTN
- U1111-1322-0220
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors, Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Atavistik Bio Inc.
- Sponsor organisation
- Atavistik Bio Inc.
- Address
- 101 Cambridgepark Dr Ste 3
- City
- Cambridge
- Postcode
- 02140-2910
- Country
- United States
Scientific contact point
- Organisation
- Atavistik Bio Inc.
- Contact name
- Patrick McNamara
Public contact point
- Organisation
- Atavistik Bio Inc.
- Contact name
- Patrick McNamara
Locations
4 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 8 | 2 |
| France | Ended | 20 | 4 |
| Italy | Ended | 8 | 2 |
| Spain | Ended | 28 | 7 |
| Rest of world
Korea, Republic of, United States, Singapore
|
— | 70 | — |
Investigational sites
UZ Leuven
Oncology, Herestraat 49, 3000, Leuven
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Institut Bergonie
Medical oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Curie
Medical oncology, 26 Rue D Ulm, 75005, Paris
Centre Leon Berard
Medical oncology, 28 Rue Laennec, 69008, Lyon
Oncopole Claudius Regaud
Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncology, Via Mariano Semmola 52, 80131, Naples
Istituto Europeo Di Oncologia S.r.l.
Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Hm Sanchinarro
Phase I Trials, Calle Ona 10, 28050, Madrid
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
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 |
|---|---|---|---|---|---|
| France | 2025-11-18 | 2025-12-19 | 2026-01-15 | ||
| Spain | 2025-10-22 | 2025-11-18 | 2026-01-15 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-10 | France | Acceptable with conditions 2025-09-15
|
2025-09-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-08 | France | Acceptable 2026-01-28
|
2026-01-28 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-01 | France | Acceptable 2026-01-28
|
2026-04-01 |