Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
180
Countries
3
Sites
7
Advanced or Metastatic Solid Tumors
Key facts
- Sponsor
- Olema Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 8 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-523686-15-00
- ClinicalTrials.gov
- NCT06784193
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or Metastatic Solid Tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Olema Pharmaceuticals Inc.
- Sponsor organisation
- Olema Pharmaceuticals Inc.
- Address
- 780 Brannan Street
- City
- San Francisco
- Postcode
- 94103-4919
- Country
- United States
Scientific contact point
- Organisation
- Olema Pharmaceuticals Inc.
- Contact name
- Melissa Bernardino
Public contact point
- Organisation
- Olema Pharmaceuticals Inc.
- Contact name
- Melissa Bernardino
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 30 | 3 |
| Ireland | Ongoing, recruiting | 6 | 1 |
| Spain | Authorised, recruiting | 12 | 3 |
| Rest of world
United States, Australia, Hong Kong
|
— | 132 | — |
Investigational sites
Fondation Hopital Saint Joseph
Oncologie, 185 Rue Raymond Losserand, 75014, Paris
Institut De Cancerologie De L Ouest
Oncologie Médicale, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Gustave Roussy
Innovation thérapeutique et essais cliniques précoces, 114 Rue Edouard Vaillant, 94800, Villejuif
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 | 2026-05-15 | ||||
| Ireland | 2026-04-08 | 2026-05-11 | |||
| Spain | 2026-04-17 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-11 | Spain | Acceptable 2026-03-15
|
2026-03-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-17 | Spain | Acceptable 2026-03-15
|
2026-04-17 |