Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Not authorised
Participants planned
3
Countries
1
Sites
1
NA
NA
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-04-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
NA
Secondary objectives 1
- N/A
Conditions and MedDRA coding
NA
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- N/A
Exclusion criteria 1
- N/A
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- N/A
Secondary endpoints 1
- N/A
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD9581693 · Product
- Active substance
- Mosunetuzumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 45 mg milligram(s)
- Max total dose
- 1035 mg milligram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9581694 · Product
- Active substance
- Mosunetuzumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 45 mg milligram(s)
- Max total dose
- 1035 mg milligram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Clinical Trial Accountable
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Clinical Trial Accountable
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Not authorised | 1 | 1 |
| Rest of world
United Kingdom, Japan
|
— | 2 | — |
Investigational sites
Roche
dummy information, Dantestraat 75, 1070, Anderlecht
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-21 | Acceptable 2024-04-25
|
2024-04-29 |