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JOURNAL ONKOLOGIE – STUDIE
IPAX-2

131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)

Rekrutierend

NCT-Nummer:
NCT05450744

Studienbeginn:
April 2023

Letztes Update:
19.07.2023

Wirkstoff:
131I-IPA

Indikation (Clinical Trials):
Glioblastoma, Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Telix International Pty Ltd

Collaborator:
-

Studienlocations
(3 von 6)

Gold Coast University Hospital
Gold Coast
AustraliaNoch nicht rekrutierend» Google-Maps
Olivia Newton John Cancer Research Institute/Austin Health
Melbourne
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Principal Investigator, MD
Phone: (03) 9496 5726
E-Mail: enquiries@onjcri.org.au» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

This is an open label, single arm, parallel-group, multicentre, and dose finding study to

evaluate the safety of ascending radioactive dose levels of 131I-TLX101 administered

intravenously in combination with best standard of care in newly diagnosed GBM patients.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Understand and voluntarily sign the informed consent form prior to any study related

procedure and/or assessments being conducted.

2. Are Male or Female, and aged 18-65 years of age inclusive, 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 ≥3,000/mL 7.1.2 Absolute neutrophil count ≥1500/mL

7.1.3 Platelets ≥100,000/mL 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.

Exclusion Criteria:

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 a medically documented history of or active major depressive episode, bipolar

disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of

suicidal attempt or ideation, or homicidal ideation (e.g., risk of doing harm to self

or others), or patients with active severe personality disorders.

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 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

Studien-Rationale

Primary outcome:

1. Incidence rate and the grade (severity) of DLTs (Time Frame - 8 weeks from the first dose of IMP until discharge from the second dosem, up to 62 weeks.):
Incidence rate and the grade (severity) of DLTs based on the occurrence of Adverse Events (AEs) reported according to the NCI CTCAE v6.0. DLTs include any grade ≥ 3 events considered possibly related to the study drug, but excludes cerebral oedema, and haematological toxicity.

2. Safety, tolerability and RP2D (Time Frame - From screening until end of study, assessed over 62 weeks. TEAEs - units are frequency (percentage) and severity. Laboratory - safety laboratory including liver functions test, report mean and out of range.):
Assessing TEAEs type according to MedDRA (Medical Dictionary for Regulatory Activities), frequency, severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0, seriousness, and relationship of study treatment will be assessed. Laboratory abnormalities will be assessed according to the NCI CTCAE V5.0.

Geprüfte Regime

  • 131I-IPA (18F-FET):
    131I-IPA: injection/solution administrated intravenously via infusion in ascending doses 18F-FET: injection/solution administrated intravenously

Quelle: ClinicalTrials.gov


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