A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients with Newly Diagnosed Glioblastoma
- Conditions
- Glioblastoma - Brain Tumor10029211
- Registration Number
- NL-OMON53391
- Lead Sponsor
- Telix Pharmaceuticals (Innovations) Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 3
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
GBM.
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.
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
the study.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To determine the safety and tolerability of 131I-TLX-101 in combination with<br /><br>standard of care treatment in newly diagnosed Glioblastoma (GBM)<br /><br>patients, by determining the Dose Limiting Toxicities (DLT), Maximum Tolerated<br /><br>Dose (MTD) and Recommended Phase 2 Dose (RP2D). This will be done by assessing<br /><br>TEAEs type (treatment emergent adverse events) type according to MedDRA,<br /><br>frequency, severity according to NCI CTCAE V5.0, seriousness, and relationship<br /><br>of study treatment will be assessed. Laboratory abnormalities will be assessed<br /><br>according to the NCI CTCAE V5.0.<br /><br>- Incidence rate and the grade (severity) of DLTs based on the occurrence of<br /><br>Adverse Events (AEs) reported according to the NCI CTCAE v5.0. DLTs include any<br /><br>grade >= 3 events considered possibly related to the study drug, but excludes<br /><br>cerebral oedema, and haematological toxicity.</p><br>
- Secondary Outcome Measures
Name Time Method