EUCTR2021-000423-12-NL进行中（未招募）1 期
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. - TUMAGNOSTIC (CP506-001)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 6 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:
- •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)
- •Measurable disease on CT scan (RECIST 1.1)
- •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
- •If male, must agree to use contraception during the treatment period and for at least 4 weeks after the last dose of study treatment
- •Able and willing to comply with the protocol Module 1 - monotherapy
- •Have histologically or cytologically-confirmed advanced or metastatic solid tumour for whom no standard of care or known effective treatment options are available
- •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
- •Patient must be eligible to carboplatin treatment.
- •Have histologically or cytologically-confirmed advanced or metastatic solid tumour for whom no standard of care or known effective treatment options are available.
- •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; 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) but the treatment has been discontinued due to toxicity.
- •Module 3 - ICI combination
- •Have histologically or cytologically-confirmed advanced or metastatic solid tumour
- •Receiving immune checkpoint inhibitor (ICI) monotherapy as standard of care for at least 6 months p
排除标准
- •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)
- •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
- •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
- •Patient or physician plans concomitant chemotherapy, radiation therapy, hormonal and/or biological treatment for cancer including immunotherapy while on study
- •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
- •Less than 4 weeks since prior major surgery
- •Known positive for HIV, Hepatitis B surface antigen positive or Hepatitis C positive with abnormal liver function tests
- •Known allergy to alkylating agents
- •Central nervous system (CNS) metastases, with the following exception:
- •Participants with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to randomization.
- •Invasive malignancy or history of invasive malignancy other than disease under study within the last 3 years, except as noted below:
- •Autoimmune disease (current or history; refer to Table 19) or syndrome that required systemic treatment within the past 2 years
- •Has a diagnosis of immunodeficiency or is receiving systemic steroids (>10 mg oral prednisone per day or equivalent) or other immunosuppressive agents within 7 days prior to randomization Note:
- •Receipt of any live vaccine within 30 days prior randomization
- •Prior allogeneic/autologous bone marrow or solid organ transplantation
- •Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents
- •Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions
- •Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intraabdominal abscess
- •Recent history of allergen desensitization therapy within 4 weeks of randomization
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