NL-OMON51911招募中不适用
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 - TUMAGNOSTIC (CP506-001)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female, aged 18 years or more at the time of signing the informed
- •2. Be willing and able to provide written informed consent for the trial
- •3. Life expectancy of at least 6 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. Able and willing to comply with the protocol
- •Module 1 - monotherapy
- •9. Have histologically or cytologically-confirmed advanced or metastatic solid
- •tumor for whom no standard of care or known effective treatment options are
- •10. 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/CLIA
- •certified (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
- •Have cancers with an increased incidence of HRD/FAD: ovarian (41%), breast
- •(18%), pancreas (10%), prostate (9%), and head and neck (5%)
- •Patients who were previously responsive to alkylating agent (Partial
- •Response/Complete Response according to RECIST criteria).
- •Module 2 - Carboplatin combination
- •11. Have histologically or cytologically-confirmed advanced or metastatic solid
- •tumor for which carboplatin is the standard of care: ovarian cancer and triple
- •negative breast cancer.
- •Module 3 - ICI combination
- •12. Have histologically or cytologically-confirmed advanced or metastatic solid
- •13. 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
排除标准
- •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
- •pacemaker. 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
- •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:
- •Participants with asymptomatic CNS metastases who are clinically stable and
- •have no requirement for steroids for at least 14 days prior to inclusion. Note:
- •Participants with carcinomatous meningitis or leptomeningeal spread are
- •excluded regardless of clinical stability
- •16. Invasive malignancy or history of invasive malignancy other than disease
- •under study within the last 3 years, except as noted below:
- •16.1. Any other invasive malignancy for which the participant was definitively
- •treated, has been disease-free for <= 3 years and in the opinion of the
- •principal investigator will not affect the evaluation of the effects of the
- •study treatment on the currently targeted malignancy, may be included in this
- •clinical study
- •16.2. Curatively treated non-melanoma skin cancer or successfully treated in
- •situ carcinoma
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