Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
90
Countries
3
Sites
11
Extensive-Stage Small Cell Lung Cancer
Key facts
- Sponsor
- Fortvita Biologics (USA) Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-04-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-523972-21-00
- ClinicalTrials.gov
- NCT06613009
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Extensive-Stage Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041068 | Small cell lung cancer extensive stage | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fortvita Biologics (USA) Inc.
- Sponsor organisation
- Fortvita Biologics (USA) Inc.
- Address
- 319 Bernardo Avenue, CA CA
- City
- Mountain View
- Postcode
- 94043-5225
- Country
- United States
Scientific contact point
- Organisation
- Fortvita Biologics (USA) Inc.
- Contact name
- Innovent Biologics (Suzhou) Co., Ltd - Department of Medical Science and Strategic Oncology.
Public contact point
- Organisation
- Fortvita Biologics (USA) Inc.
- Contact name
- Innovent Biologics (Suzhou) Co., Ltd - Department of Medical Science and Strategic Oncology.
Locations
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 10 | 3 |
| Poland | Authorised, recruitment pending | 10 | 4 |
| Spain | Authorised, recruitment pending | 10 | 4 |
| Rest of world
China, Australia, United Kingdom, United States, Canada
|
— | 60 | — |
Investigational sites
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Department of Oncology, J. B. Winsloews Vej 4, 5000, Odense C
Region Hovedstaden
Dept of Oncology, Phase 1 Clinic, Borgmester Ib Juuls Vej 1, 2730, Herlev
Uniwersyteckie Centrum Kliniczne
Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Pratia S.A.
Pratia Poznań, Ul. Gryfinska 1, 60-192, Poznan
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
NA, Ul. Wladyslawa Stanislawa Reymonta 83/91, 05-400, Otwock
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Płuca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-19 | Denmark | Acceptable 2026-04-27
|
2026-04-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-13 | Acceptable 2026-04-27
|
2026-05-13 |