Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
430
Countries
2
Sites
10
colorectal cancer
Key facts
- Sponsor
- IGM Biosciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Nov 2023 → 5 Nov 2024
- Decision date (initial)
- 2023-10-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504545-31-00
- ClinicalTrials.gov
- NCT04553692
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
colorectal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
IGM Biosciences Inc.
- Sponsor organisation
- IGM Biosciences Inc.
- Address
- 325 East Middlefield Road
- City
- Mountain View
- Postcode
- 94043-4003
- Country
- United States
Scientific contact point
- Organisation
- IGM Biosciences Inc.
- Contact name
- Eric Humke
Public contact point
- Organisation
- IGM Biosciences Inc.
- Contact name
- Eric Humke
Locations
2 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 5 |
| Spain | Ended | 10 | 5 |
| Rest of world
Korea, Republic of, United States, Australia
|
— | 408 | — |
Investigational sites
Institut Gustave Roussy
Drug Development and GI Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Medical Oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Institut Bergonie
Medical Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Hopital Saint Louis
Hepato-Gastroenterology and Digestive Oncology, 1 Avenue Claude Vellefaux, 75010, Paris
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, 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 | 2023-11-29 | 2023-12-11 | 2024-05-31 | ||
| Spain | 2023-11-23 | 2024-01-10 | 2024-05-31 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-12 | Spain | Acceptable 2023-10-18
|
2023-10-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-17 | Spain | Acceptable 2023-10-18
|
2023-11-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-17 | Acceptable | 2024-01-08 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-10 | Spain | Acceptable 2024-02-22
|
2024-02-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-09 | Spain | Acceptable | 2024-09-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-20 | Acceptable | 2024-09-30 |