Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
155
Countries
1
Sites
6
Advanced solid tumors
Key facts
- Sponsor
- Zymeworks 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], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 18 Feb 2026 → ongoing
- Decision date (initial)
- 2025-03-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512299-37-00
- ClinicalTrials.gov
- NCT06555744
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 21.0 | PT | 10014733 | Endometrial cancer | 100000004864 |
| 20.0 | PT | 10061328 | Ovarian epithelial cancer | 100000004864 |
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Zymeworks Inc.
- Sponsor organisation
- Zymeworks Inc.
- Address
- 1385 8th Avenue West Suite 540
- City
- Vancouver
- Postcode
- V6H 3V9
- Country
- Canada
Scientific contact point
- Organisation
- Zymeworks Inc.
- Contact name
- Medical Officer
Public contact point
- Organisation
- Zymeworks Inc.
- Contact name
- Medical Officer
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 18 | 6 |
| Rest of world
United States, Australia, Korea, Republic of, Japan, Singapore
|
— | 137 | — |
Investigational sites
Hospital Universitario Quironsalud Madrid
Medical Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Fundacion Instituto Valenciano De Oncologia
Medical Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Clinico Universitario De Valencia
Medical Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Reina Sofia
Medical Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
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 |
|---|---|---|---|---|---|
| Spain | 2026-02-18 | 2026-02-25 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-28 | Spain | Acceptable with conditions 2025-03-21
|
2025-03-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-28 | Spain | Acceptable 2025-11-18
|
2025-11-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-03 | Spain | Acceptable 2026-02-13
|
2026-02-17 |