Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, 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 | Ongoing, recruiting | 30 | 3 |
| Ireland | Ongoing, recruiting | 6 | 1 |
| Spain | Ongoing, recruiting | 12 | 3 |
| Rest of world
Hong Kong, Australia, United States
|
— | 132 | — |
Investigational sites
Institut Gustave Roussy
Innovation thérapeutique et essais cliniques précoces, 114 Rue Edouard Vaillant, 94800, Villejuif
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
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 | 2026-05-27 | |||
| Ireland | 2026-04-08 | 2026-05-11 | |||
| Spain | 2026-04-17 | 2026-06-04 |
Application history
3 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 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-30 | Acceptable 2026-07-03
|
2026-07-03 |