Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
180
Countries
1
Sites
3
Advanced or metastatic ovarian cancer, NSCLC, pancreatic cancer, and other mesothelin expressing cancers
Key facts
- Sponsor
- Zymeworks Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Mar 2025 → 2 Oct 2025
- Decision date (initial)
- 2024-10-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or metastatic ovarian cancer, NSCLC, pancreatic cancer, and other mesothelin expressing cancers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 20.0 | LLT | 10079440 | Non-squamous non-small cell lung cancer | 10029104 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 21.0 | LLT | 10033604 | Pancreatic cancer | 10029104 |
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 · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 25 | 3 |
| Rest of world
United Kingdom, United States, Korea, Republic of
|
— | 155 | — |
Investigational sites
Technische Universitaet Dresden
Med. Fak. Carl Gustav Carus Nat. Centrum für Tumorerkrankungen Dresden Early Clinical Trial Unit, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Goethe University Frankfurt
Universitaetsklinikum Frankfurt, Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
III. Medizinische Klinik und Poliklinik: Haematologie und Medizinische Onkologie, Langenbeckstrasse 1, Oberstadt, Mainz
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 |
|---|---|---|---|---|---|
| Germany | 2025-03-07 | 2025-03-07 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-01 | Germany | Acceptable 2024-10-10
|
2024-10-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-09 | Germany | Acceptable 2025-01-22
|
2025-01-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-05 | Germany | Acceptable 2025-01-22
|
2025-02-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-20 | Germany | Acceptable 2025-05-15
|
2025-05-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-24 | Germany | Acceptable 2025-10-02
|
2025-10-06 |