A modular, first time in human, open label, multiple dose, accelerated escalation with cohort expansion study of the safety and pharmacokinetics of intravenous infusion of CP-506, a tumor agnostic Hypoxia Activated Prodrug in patients with HRD/FAD solid tumors or tumor types with high incidence of HRD/FAD in monotherapy or in combination with carboplatin or patients with solid tumor and oligoprogressive disease receiving immune checkpoint inhibitors (ICI): a phase I-IIa clinical trial.

2023-506818-45-00 Phase I and Phase II (Integrated) - First administration to humans Ongoing, recruiting

Start 13 Dec 2022 · Status Ongoing, recruiting · 3 EU/EEA countries · 5 sites

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - First administration to humans
Status Ongoing, recruiting
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
Universiteit Maastricht
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

Universiteit Maastricht

6 Total trials 1 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Universiteit Maastricht
Address
P. O. Box 616
City
Maastricht
Postcode
6200 MD
Country
Netherlands

Scientific contact point

Organisation
Universiteit Maastricht
Contact name
Anke Smets

Public contact point

Organisation
Universiteit Maastricht
Contact name
Anke Smets

Locations

3 EU/EEA countries · 5 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruiting 50 2
Netherlands Ongoing, recruiting 84 2
Spain Authorised, recruitment pending 25 1
Rest of world — 0 —

Investigational sites

Belgium

2 sites · Ongoing, recruiting
Universitair Ziekenhuis Gent
Medical Oncology, Corneel Heymanslaan 10, 9000, Gent
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht

Netherlands

2 sites · Ongoing, recruiting
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

Spain

1 site · Authorised, recruitment pending
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2025-10-08 2025-12-10
Netherlands 2022-12-13 2023-05-30

Application history

5 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision 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

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