Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
408
Countries
3
Sites
25
Solid Tumors
Key facts
- Sponsor
- Theras Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Oct 2025 → ongoing
- Decision date (initial)
- 2025-04-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519445-29-00
- ClinicalTrials.gov
- NCT06625775
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Theras Inc.
- Sponsor organisation
- Theras Inc.
- Address
- 256 East Grand Avenue Suite 104
- City
- South San Francisco
- Postcode
- 94080-4811
- Country
- United States
Scientific contact point
- Organisation
- Theras Inc.
- Contact name
- CTIS Contact Point
Public contact point
- Organisation
- Theras Inc.
- Contact name
- CTIS Contact Point
Locations
3 EU/EEA countries · 25 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 29 | 6 |
| Italy | Authorised, recruitment pending | 16 | 8 |
| Spain | Ongoing, recruiting | 46 | 11 |
| Rest of world
Korea, Republic of, Australia, United States, Brazil
|
— | 317 | — |
Investigational sites
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Department of Therapeutic Innovation and Early Trials, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Regional Du Cancer De Montpellier
Medical Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut Curie
Medical Oncology, 35 Rue Dailly, 92210, Saint-Cloud
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Fondazione IRCCS Istituto Nazionale Dei Tumori
Phase 1 Unit, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliero Universitaria Delle Marche
Dpt Internal Medicine- SOD Clinic Oncology, Via Conca 71, 60126, Ancona
Istituto Europeo Di Oncologia S.r.l.
Development of New Drugs for Innovative Therapies, Via Giuseppe Ripamonti 435, 20141, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncology division, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero Universitaria Careggi
Clinical Oncology Departmental Unit, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Phase 1, Largo Francesco Vito 1, 00168, Rome
Centro Di Riferimento Oncologico Di Aviano
Medical Oncology and Cancer Prevention, Via Franco Gallini 2, 33081, Aviano
Ospedale San Raffaele S.r.l.
Oncology Medicine Unit, Via Olgettina 60, 20132, Milan
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Oncology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Beata Maria Ana
Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, 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 |
|---|---|---|---|---|---|
| France | 2025-10-02 | 2025-12-29 | |||
| Spain | 2025-10-02 | 2026-02-11 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-11 | Spain | Acceptable 2025-04-03
|
2025-04-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-24 | Spain | Acceptable 2025-04-03
|
2025-04-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-06 | Spain | Acceptable 2025-12-19
|
2025-12-19 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2026-02-05 | 2026-04-29 |