Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaastricht University Medical Center
About this trial
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 tumours or tumor types with high incidence of HRD/FAD in monotherapy or in combination with carboplatin or patients with solid tumour and oligoprogressive disease receiving immune checkpoint inhibitors (ICI): a phase I-IIa clinical trial
Eligibility criteria
Qualifiers
Male or female, aged 18 years or more at the time of signing the informed consent
Be willing and able to provide written informed consent for the trial
Life expectancy of at least 3 months
Be willing to have a biopsy collection procedure
Disqualifiers
Prior radiotherapy to more than 25% of bone marrow
Not recovered from all acute toxic effects of prior anticancer therapy (excluding CTCAE Grade 1 alopecia or peripheral neuropathy)
Patients with significant cardiac co-morbidity, such as NYHA Class III or IV CHF, unstable angina, MI within the previous 6 months, or ventricular arrhythmias requiring drug therapy, pacemaker or implanted defibrillator. Serious, uncontrolled cardiac arrhythmia or clinically significant electrocardiogram abnormalities including second degree (Type II) or third-degree atrioventricular block. This does not apply to patient with a pace maker. Cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting or bypass grafting. Congestive heart failure (Class II, III, or IV) as defined by the New York Heart Association functional classification system. Symptomatic pericarditis
A marked baseline prolongation of QT/QTc interval (> 450 ms)
Trial design
Treatments tested in this trial
- CP-506
- Carboplatin
- Immune checkpoint inhibitor
Treatment groups
126 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Maastricht University Medical Center
Lead sponsor
Erasmus Medical Center
Collaborator
Jules Bordet Institute
Collaborator
Academisch Ziekenhuis Maastricht
Collaborator
Vall d'Hebron Institute of Oncology
Collaborator
University Ghent
Collaborator
Source ClinicalTrials.gov