Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
58
Countries
3
Sites
9
Advanced Epithelial Ovarian Cancer (including Fallopian Tube or Primary Peritoneal cancers)
Key facts
- Sponsor
- Sutro Biopharma Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 23 Nov 2022 → 17 Jul 2025
- Decision date (initial)
- 2024-11-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513708-33-00
- EudraCT number
- 2021-006293-23
- ClinicalTrials.gov
- NCT05200364
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Epithelial Ovarian Cancer (including Fallopian Tube or Primary Peritoneal cancers)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sutro Biopharma Inc.
- Sponsor organisation
- Sutro Biopharma Inc.
- Address
- 111 Oyster Point Boulevard
- City
- South San Francisco
- Postcode
- 94080-2037
- Country
- United States
Scientific contact point
- Organisation
- Sutro Biopharma Inc.
- Contact name
- Director, Clinical Operations
Public contact point
- Organisation
- Sutro Biopharma Inc.
- Contact name
- Director, Clinical Operations
Locations
3 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 5 | 2 |
| Italy | Ended | 5 | 3 |
| Spain | Ended | 10 | 4 |
| Rest of world
United States
|
— | 38 | — |
Investigational sites
Institut De Cancerologie De L Ouest
Oncologie, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Leon Berard
Oncologie, 28 Rue Laennec, 69008, Lyon
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Sperimentazioni Cliniche, Via Mariano Semmola 52, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità di ginecologia oncologica, ginecologia e ostetricia, Largo Francesco Vito 1, 00168, Rome
Istituto Europeo Di Oncologia S.r.l.
Divisione Sviluppo Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 | 2024-10-25 | 2024-10-31 | 2025-03-28 | ||
| Italy | 2023-01-16 | 2024-04-17 | 2025-03-28 | ||
| Spain | 2022-11-23 | 2022-12-19 | 2025-03-28 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Spain | Acceptable 2024-11-04
|
2024-11-04 |