Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
159
Countries
3
Sites
5
Solid tumors that have a high incidence of Homologous Recombination (HRD) or Fanconi Anemia (FAD) DNA damage repair deficiency.
Key facts
- Sponsor
- Convert Pharmaceuticals
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Dec 2022 → ongoing
- Decision date (initial)
- 2025-06-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506818-45-00
- EudraCT number
- 2021-000423-12
- ClinicalTrials.gov
- NCT04954599
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid tumors that have a high incidence of Homologous Recombination (HRD) or Fanconi Anemia (FAD) DNA damage repair deficiency.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Convert Pharmaceuticals
- Sponsor organisation
- Convert Pharmaceuticals
- Address
- Esplanade Simone Veil 1
- City
- Liege
- Postcode
- 4000
- Country
- Belgium
Scientific contact point
- Organisation
- Convert Pharmaceuticals
- Contact name
- Helene Devroye
Public contact point
- Organisation
- Convert Pharmaceuticals
- Contact name
- Amelie Vanneste
Locations
3 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Temporarily halted | 50 | 2 |
| Netherlands | Temporarily halted | 84 | 2 |
| Spain | Authorised, recruitment pending | 25 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Ziekenhuis Gent
Medical Oncology, Corneel Heymanslaan 10, 9000, Gent
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Maastricht University Medical Center
Medical oncology, P Debyelaan 25, 6229HX, Maastricht
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 60, 3015 GJ, Rotterdam
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 |
|---|---|---|---|---|---|
| Belgium | 2025-10-08 | 2025-12-10 | 2026-06-05 | ||
| Netherlands | 2022-12-13 | 2023-05-30 | 2026-06-05 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-137651
- Halt date
- 2026-06-05
- Planned restart
- 2026-09-01
- Member states concerned
- Belgium
- Publication date
- 2026-06-05
- Reason
- Medicinal Product related
- Explanation
- Recruitment is temporarily halted due to a shortage of the investigational medicinal product. We have prepared a new batch of product but we changed the manufacturer and manufacturing process, therefore we will need to submit an updtaed IMPD and this will take more time than the shelf life of our current batch.
- Follow-up measures
- Treatment of the two ongoing patients can be done with what we have left of the previous batch
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-137653
- Halt date
- 2026-06-05
- Planned restart
- 2026-09-01
- Member states concerned
- Netherlands
- Publication date
- 2026-06-05
- Reason
- Medicinal Product related
- Explanation
- Recruitment is temporarily halted due to a shortage of the investigational medicinal product. We have prepared a new batch of product but we changed the manufacturer and manufacturing process, therefore we will need to submit an updtaed IMPD and this will take more time than the shelf life of our current batch.
- Follow-up measures
- Treatment of the two ongoing patients can be done with what we have left of the previous batch
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-24 | Netherlands | Acceptable 2024-06-06
|
2024-06-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-16 | Netherlands | Acceptable 2025-01-07
|
2025-01-07 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-04-30 | 2025-06-30 | ||
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-04-30 | 2025-07-16 | ||
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-04 | Netherlands | 2026-05-04 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-06-24 | Netherlands | Acceptable 2026-06-30
|
2026-06-30 |