Clinical trial • Phase I/II • Oncology
Carboplatin for Solid tumours with homologous recombination deficiency (HRD) / Fanconi anemia (FAD) DNA damage repair deficiency
Phase I/II trial of Carboplatin for Solid tumours with homologous recombination deficiency (HRD) / Fanconi anemia (FAD) DNA damage repair deficiency.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Solid tumours with homologous recombination deficiency (HRD) / Fanconi anemia (FAD) DNA damage repair deficiency
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 24-05-2024
- First CTIS Authorization Date
- 06-06-2024
Trial design
open-label, adaptive Phase I/II trial across 5 sites in Netherlands, Belgium, Spain.
- Open Label
- Yes
- Adaptive
- True, accelerated escalation with cohort expansion (multiple-dose accelerated dose-escalation with cohort expansion as described in the public title)
- Biomarker Stratified
- True, HRD/FAD (homologous recombination deficiency / Fanconi anemia DNA repair deficiency)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 159
Recruitment
- Planned Sample Size
- 159
- Recruitment Window Months
- 50
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 159
Netherlands
- Earliest CTIS Part Ii Submission Date
- 31-05-2024
- Latest Decision Or Authorization Date
- 06-06-2024
- Processing Time Days
- 6
- Number Of Sites
- 2
- Number Of Participants
- 84
Sites
- Site Name
- Maastricht University Medical Center
- Department Name
- Medical oncology
- Contact Person Name
- Loes Jansen
- Contact Person Email
- loes.jansen@mumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- Contact Person Name
- Henk Verheul
- Contact Person Email
- h.verheul@erasmusmc.nl
Belgium
- Earliest CTIS Part Ii Submission Date
- 16-06-2025
- Latest Decision Or Authorization Date
- 30-06-2025
- Processing Time Days
- 14
- Number Of Sites
- 2
- Number Of Participants
- 50
Sites
- Site Name
- Institut Jules Bordet
- Department Name
- Medical Oncology
- Contact Person Name
- Nuria Kotecki
- Contact Person Email
- nuria.kotecki@hubruxelles.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Medical Oncology
- Contact Person Name
- Sylvie Rottey
- Contact Person Email
- sylvie.rottey@ugent.be
Spain
- Earliest CTIS Part Ii Submission Date
- 24-06-2025
- Latest Decision Or Authorization Date
- 16-07-2025
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 25
Sites
- Site Name
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Department Name
- Medical Oncology
- Contact Person Name
- Irene Brana
- Contact Person Email
- ibrana@vhio.net
Sponsor
Primary sponsor
- Full Name
- Universiteit Maastricht
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- CP-506
- Modality
- Small molecule
- Routes Of Administration
- intravenous infusion
- Route
- intravenous
- Authorisation Status
- Investigational (first-in-human)
- First In Human
- Yes
- Frequency
- multiple dose
- Investigational Product Name
- Carboplatin
- Active Substance
- Carboplatin
- Modality
- Small molecule
- Investigational Product Name
- Immune checkpoint inhibitors (ICI)
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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