Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
82
Countries
1
Sites
4
Phase 1: Advanced solid tumors harboring genetic alterations in MET
Key facts
- Sponsor
- Turning Point Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Dec 2020 → ongoing
- Decision date (initial)
- 2024-07-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510450-16-00
- EudraCT number
- 2019-002459-40
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Phase 1: Advanced solid tumors harboring genetic alterations in MET
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Turning Point Therapeutics Inc.
- Sponsor organisation
- Turning Point Therapeutics Inc.
- Address
- 10628 Science Center Drive Suite 200 Suite 225
- City
- San Diego
- Postcode
- 92121-1124
- Country
- United States
Scientific contact point
- Organisation
- Turning Point Therapeutics Inc.
- Contact name
- GSM-CT; Organisation name: Bristol Myers Squibb International Corporation
Public contact point
- Organisation
- Turning Point Therapeutics Inc.
- Contact name
- GSM-CT; Organisation name: Bristol Myers Squibb International Corporation
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 14 | 4 |
| Rest of world
Korea, Republic of, United States
|
— | 68 | — |
Investigational sites
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Médecine Oncologique, 114 Rue Edouard Vaillant, 94800, Villejuif
Unite De Recherche Clinique HIA Begin
Clinical Research Unit, 69 Avenue De Paris, 94160, Saint-Mande
Centre Hospitalier Universitaire Grenoble Alpes
Pneumology and Physiology Unit, Boulevard De La Chantourne, 38700, La Tronche
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 | 2020-12-16 | 2020-12-16 | 2023-04-14 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-26 | France | Acceptable 2024-07-05
|
2024-07-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-10 | France | Acceptable 2024-11-07
|
2024-11-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-25 | France | Acceptable 2025-08-04
|
2025-08-04 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-21 | France | Acceptable 2025-08-04
|
2025-10-21 |