Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
3,999,996
Countries
3
Sites
20
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]
- Decision date (initial)
- 2026-06-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-524690-16-00
- ClinicalTrials.gov
- NCT06917079
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid Tumors
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 · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 999,999 | 8 |
| Italy | Authorised, recruitment pending | 999,999 | 5 |
| Spain | Authorised, recruitment pending | 999,999 | 7 |
| Rest of world
Turkey, Korea, Republic of, Taiwan, Brazil, United Kingdom, United States, Australia, Canada
|
— | 999,999 | — |
Investigational sites
Centre Hospitalier Regional De Marseille
Oncology, 264 Rue Saint Pierre, 13005, Marseille
Institut Regional Du Cancer De Montpellier
Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut Bergonie
Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut De Cancerologie De Lorraine
Oncology, 6 Avenue De Bourgogne, 54500, Vandouvre Les Nancy
Institut Gustave Roussy
Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Oscar Lambret
Oncology, 3 Rue Frederic Combemale, 59000, Lille
Hospices Civils De Lyon
Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Institut Curie
Oncology, 26 Rue D Ulm, 75005, Paris
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Fase 1, Largo Francesco Vito 1, 00168, Rome
Ospedale San Raffaele S.r.l.
Oncologia Medica, Via Olgettina 60, 20132, Milan
Istituto Europeo Di Oncologia S.r.l.
Divisione Sviluppo di nuovi farmaci per terapie innovative, Via Giuseppe Ripamonti 435, 20141, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Melanoma Cancer Immunotherapy and Development therapeutics Unit, Via Mariano Semmola 52, 80131, Naples
Istituto Oncologico Veneto
Oncologia, Via Gattamelata 64, 35128, Padova
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 Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Miguel Servet
Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-27 | Spain | Acceptable 2026-06-15
|
2026-06-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-06-24 | Acceptable 2026-06-15
|
2026-06-24 |