NL-OMON53391尚未招募不适用
A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients with Newly Diagnosed Glioblastoma - IPAX-2
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3
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. Understand and voluntarily sign the informed consent form prior to any study
- •relatedprocedure and/or assessments being conducted.
- •2. Are Male or Female, and aged 18 and older, at the time of signing the
- •informed consent.
- •3. Have histologically confirmed intracranial glioblastoma (per WHO 2021
- •definition) following surgical resection. Tumours primarily localised in the
- •infratentorial compartment will be excluded.
- •4. Have had prior surgery for glioblastoma, but no systemic therapy or
- •radiation therapy for
- •5. Have a Karnofsky Performance Status >=70.
- •6. Plan to begin chemoradiation therapy 3-6 weeks after surgical resection with
- •Stupp regimen.
- •7. Have adequate organ function at Screening:
- •7.1 Bone marrow:
- •7.1.1 Leukocytes >=3x10^9/L
- •7.1.2 Absolute neutrophil count >=1.5x10^9/L
- •7.1.3 Platelets >=100x10^9/L
- •7.1.4 Haemoglobin >=9g/dL
- •7.2 Liver function:
- •7.2.1 Total bilirubin <=1.5×the upper limit of normal (ULN). For patients with
- •known Gilbert*s Syndrome <=3×ULN is permitted
- •7.2.2 Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- •<=2.5×ULN
- •7.3 Renal function:
- •7.3.1 Serum/plasma creatinine <=1.5×ULN or creatinine clearance >=50 mL/min
- •8. Have at least 6 slides without staining or a tissue block (frozen or
- •paraffin-embedded) available from a previous biopsy or surgery (tumour sample
- •previously archived).
- •9. Have the capacity to understand the study and be able and willing to comply
- •with all protocol requirements, including compliance with the radiation
- •protection guidelines (including hospital admissions and isolation) that are
- •applied by the treating institution to protect their contacts and the public.
- •10. Agree to practice adequate precautions to prevent pregnancy to avoid
- •potential problems associated with radiation exposure to the unborn child.
- •11. Females must have a negative pregnancy test at screening and on dosing day,
- •must not be lactating.
排除标准
- •1. Are unable to provide signed informed consent
- •2. Have had prior treatment for glioma, excluding surgery.
- •3. Are unable to undergo contrast-enhanced MRI.
- •4. Intend to be treated with tumor-treating fields prior to progression.
- •5. Have a history or evidence of delayed-type hypersensitivity (DTH)-dependent
- •chronic infection (e.g., tuberculosis, systemic fungal or parasitic infection),
- •potentially exacerbating under systemic corticoid therapy.
- •6. Have a known history of allergy TMZ, any excipient in the study medication
- •or any other intravenously administered human proteins/peptides/antibodies.
- •7. Have haemostaseologic conditions, precluding catheterisation or invasive
- •procedures.
- •8. Have phenylketonuria
- •9. Have any medical condition that in the opinion of the Investigator may
- •interfere with the participant*s ability to adhere to the study or may impose a
- •risk to the participant*s health.
- •10. Major trauma including major surgery (such as abdominal/cardiac/thoracic
- •surgery) within 3 weeks of administration of study treatment except surgery on
- •primary tumour.
- •11. Pregnant, breastfeeding or planning to get pregnant during the duration of
- •12. Requirement of chronic administration of high dose corticosteroids or other
- •immunosuppressant drugs. Limited or occasional use of corticosteroids to treat
- •or prevent acute adverse reactions is not considered an exclusion criterion.
- •13. Have presence of active and uncontrolled infections or other severe
- •concurrent disease, which, in the opinion of the investigator, would place the
- •participant at undue risk or unable to comply with study requirements.
- •HIV-positive participants may be included in the study if they are on a stable
- •dose of anti-retroviral therapy.
- •14. Have concurrent malignancies (except: basal cell carcinoma, in situ breast
- •cancer) unless the patient has been disease-free without intervention for at
- •least 2 years.
- •15. Have taken growth factors or immunomodulatory agents within 7 days prior to
- •the administration of study treatment.
- •16. Have serious, non-healing wound, ulcer, or bone fracture.
- •17. Have a requirement of concurrent use of other anti-cancer treatments or
- •agents other than study medication.
- •18. Have received any other IMP within 90 days prior to the planned
- •administration of study drug.
- •19. Have uncontrolled Hashimoto*s or Grave*s disease
- •20. Have on-going and unresolved Grade >= 1 AEs following surgical resection
研究者
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