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Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllMaastricht University Medical Center
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Male or female, aged 18 years or more at the time of signing the informed consent 2. Be willing and able to provide written informed consent for the trial 3. Life expectancy of at least 3 months 4. Be willing to have a biopsy collection procedure 5. ECOG Performance status \<= 2 6. Must have adequate organ and bone marrow function, defined as the following: 6.1. 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) 7. Measurable disease on CT scan (RECIST 1.1) 8. If female, not pregnant, not breastfeeding, and at least one of the following conditions applies: 8.1. Not a woman of childbearing potential (WOCBP) 8.2. A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment and shows a negative pregnancy test before the start of the treatment 9. If male, must agree to use contraception during the treatment period and for at least 4 weeks after the last dose of study treatment 10. Able and willing to comply with the protocol Module 1 - monotherapy 11. Have histologically or cytologically-confirmed advanced or metastatic solid tumour for whom no standard of care or known effective treatment options are available 12. Have indications of Homologous Recombination (HR) or Fanconi Anaemia (FA) DNA damage repair defects, based on hereditary cancer diagnostics (e.g. BRCA1/2 carriers), dedicated HRD genomic assays (including exome-sequencing) from liquid or tissue biopsies. Presence of such a defect must have been established via a tissue based next generation sequencing test, performed --in a CAP/CLIAcertified (or comparable local or regional certification) laboratory, or via a germline test from one of the following approved providers: Myriad Genetics; Invitae; Ambry; Quest; Color Genomics; MSKCC-IMPACT; GeneDx; Foundation Medicine OR Have cancers with an increased incidence of HRD/FAD: ovarian (41%), breast (18%), pancreas (10%), prostate (9%), and head and neck (5%) OR Patients who were previously responsive to alkylating agent (Partial Response/Complete Response according to RECIST criteria). Module 2 - Carboplatin combination 13. Patient must be eligible to carboplatin treatment. 14. Have histologically or cytologically-confirmed advanced or metastatic solid tumour for whom no standard of care or known effective treatment options are available. 15. Receive carboplatin as standard of care: triple negative breast cancer or ovarian cancer. Module 3 - ICI combination 16. Have histologically or cytologically-confirmed advanced or metastatic solid tumour 17. Receiving immune checkpoint inhibitor (ICI) monotherapy as standard of care for at least 6 months prior to the beginning of the study and who are oligoprogressive. Oligoprogression disease is defined as localized treatment failure at one or two anatomic sites, with one to five progressive and measurable (according to RECIST 1.1) lesions, either new or with ≥ 20% growth of their longest diameter (short-axis in lymph nodes), while other tumor manifestations could shrink or grow less than 20% in diameter Exclusion Criteria: Core: 1. Prior radiotherapy to more than 25% of bone marrow 2. Not recovered from all acute toxic effects of prior anticancer therapy (excluding CTCAE Grade 1 alopecia or peripheral neuropathy) 3. 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 4. A marked baseline prolongation of QT/QTc interval (\> 450 ms) 5. History of risk factors for Torsade de Pointe (e.g. heart failure, hypokalemia, family history of Long QT syndrome) 6. Use of concomitant medication prolonging the QT/QTc interval 7. Evidence of uncontrolled infection or infection requiring a concomitant parenteral antibiotic 8. Evidence of any other significant clinical disorder or laboratory finding that in the opinion of the Investigator may compromise patient safety during study participation. 9. Patients with a diagnosis (or strong suspicion) of a rare genetic disorder related to germline biallelic HR/FA and DNA repair gene mutations, such as Fanconi anemia patients of any subtype, Ataxia telangiectasia, Xeroderma pigmentosum, Cockayne, Nijmegen breakage, Werner and Bloom syndrome patients 10. Patient or physician plans concomitant chemotherapy, radiation therapy, hormonal and/or biological treatment for cancer including immunotherapy while on study 11. Patient has been treated with any investigational drug or investigational therapeutic device within 30 days (60 days in case of biological compound) of initiating study treatment 12. Less than 4 weeks since prior major surgery 13. Known positive for HIV, Hepatitis B surface antigen positive or Hepatitis C positive with abnormal liver function tests 14. Known allergy to alkylating agents 15. Central nervous system (CNS) metastases, with the following exception: 16. Participants with asymptomatic CNS metastases who are clinically stable and have no r
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What it tests

  • CP-506
  • Carboplatin
  • Immune checkpoint inhibitor
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Where

5 sites
Institut Jules Bordet
Brussels, Belgium
UZ Gent
Ghent, Belgium
Academisch Ziekenhuis Maastricht (Leading Centre)
Maastricht, Netherlands
Erasmus MC
Rotterdam, Netherlands
Institut Vall d'Hebron
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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