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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. ECOG Performance status \<= 2
✓. Must have adequate organ and bone marrow function, defined as the following:
✓.1. ANC ≥ 1500 µL 6.2. Hemoglobin ≥ 9.0 g/dL 6.3. Platelets ≥ 100 000 µL 6.4. Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \>1.5 × ULN 6.5. AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases) 6.6. Creatinine ≤ 1.5 × ULN 6.7. Coagulation: INR ≤ 1.5 × ULN (or within therapeutic ranges for participants on anticoagulant treatment)
✓. Measurable disease on CT scan (RECIST 1.1)
Exclusion criteria
✕. 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
What they're measuring
1
Incidence of treatment-emergent adverse events including dose-limiting toxicities
Timeframe: Baseline until 60 days after last administration of CP-506
2
Incidence of clinically significant abnormal measurements in physical examination, vital signs, electrocardiogram (ECG), lab tests and ECOG performance status
Timeframe: Baseline until 60 days after last administration of CP-506
✕. A marked baseline prolongation of QT/QTc interval (\> 450 ms)
✕. History of risk factors for Torsade de Pointe (e.g. heart failure, hypokalemia, family history of Long QT syndrome)
✕. Use of concomitant medication prolonging the QT/QTc interval
✕. Evidence of uncontrolled infection or infection requiring a concomitant parenteral antibiotic
✕. Evidence of any other significant clinical disorder or laboratory finding that in the opinion of the Investigator may compromise patient safety during study participation.