Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
110
Countries
2
Sites
10
Advanced Solid Tumors with AKT1 E17K Mutation
Key facts
- Sponsor
- Alterome Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Mar 2025 → 23 Apr 2026
- Decision date (initial)
- 2025-02-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515391-12-00
- ClinicalTrials.gov
- NCT06533059
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors with AKT1 E17K Mutation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 20.1 | HLGT | 10027655 | Miscellaneous and site unspecified neoplasms malignant and unspecified | 10029104 |
| 21.1 | PT | 10028980 | Neoplasm | 100000004864 |
| 20.0 | HLT | 10029111 | Neoplasms unspecified malignancy and site unspecified NEC | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Alterome Therapeutics Inc.
- Sponsor organisation
- Alterome Therapeutics Inc.
- Address
- 13480 Evening Creek Drive North Suite 450
- City
- San Diego
- Postcode
- 92128-4310
- Country
- United States
Scientific contact point
- Organisation
- Alterome Therapeutics Inc.
- Contact name
- Alterome Clinical Trial Contact Center
Public contact point
- Organisation
- Alterome Therapeutics Inc.
- Contact name
- Alterome Clinical Trial Contact Center
Locations
2 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 8 | 4 |
| Spain | Ended | 12 | 6 |
| Rest of world
Australia, Japan, United Kingdom, Taiwan, United States, Korea, Republic of
|
— | 90 | — |
Investigational sites
Institut Gustave Roussy
Département d'Innovation Thérapeutique et d'Essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Francois Baclesse
Unite d’investigation, de recherche, d’innovation et de soins (IRIS), 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centr Georges Francois Leclerc
Unite de Phase Precoce, 1 Rue Professeur Marion, 21000, Dijon
Hospital Quironsalud Barcelona
Oncología, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Clinico Universitario De Valencia
Oncología, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Institut Catala D'oncologia
Oncologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Oncología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Quironsalud Madrid
Oncología, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
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 | 2025-05-15 | 2025-07-29 | 2026-04-23 | ||
| Spain | 2025-03-15 | 2025-04-23 | 2026-04-23 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Spain | Acceptable 2025-02-17
|
2025-02-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-17 | Acceptable | 2025-04-08 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-24 | Spain | Acceptable 2025-11-24
|
2025-11-24 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-23 | Spain | Acceptable 2025-11-24
|
2025-12-23 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-07 | Spain | Acceptable 2025-11-24
|
2026-05-07 |