Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
100
Countries
3
Sites
11
Advanced Solid Tumors
Key facts
- Sponsor
- Zymeworks Bc Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Jan 2026 → ongoing
- Decision date (initial)
- 2026-01-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Zymeworks Bc Inc.
- Sponsor organisation
- Zymeworks Bc Inc.
- Address
- 1385 8th Avenue West Suite 540
- City
- Vancouver
- Postcode
- V6H 3V9
- Country
- Canada
Scientific contact point
- Organisation
- Zymeworks Bc Inc.
- Contact name
- Maggie Weinstein
Public contact point
- Organisation
- Zymeworks Bc Inc.
- Contact name
- Maggie Weinstein
Locations
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Ireland | Authorised, recruiting | 3 | 1 |
| Portugal | Ongoing, recruiting | 6 | 2 |
| Spain | Ongoing, recruiting | 22 | 8 |
| Rest of world
Taiwan, United States, Japan
|
— | 69 | — |
Investigational sites
Start Research Portugal Unipessoal Lda.
N/A, Rua Castilho 39 8º E, 1250-068, Lisbon
Unidade Local De Saude De Gaia/Espinho E.P.E.
Unidade de Fase 1, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital San Pedro
Oncology, Calle Piqueras 98, 26006, Logrono
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Virgen De La Victoria
Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Quironsalud Madrid
Oncology, 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 |
|---|---|---|---|---|---|
| Ireland | 2026-02-12 | ||||
| Portugal | 2026-01-28 | 2026-02-13 | |||
| Spain | 2026-02-09 | 2026-02-17 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-10 | Spain | Acceptable 2026-01-14
|
2026-01-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-24 | Spain | Acceptable 2026-05-28
|
2026-05-29 |