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

Primary Purpose

Neoplastic Disease, Glioblastoma, Glioblastoma Multiforme

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
131I-IPA
Sponsored by
Telix International Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplastic Disease focused on measuring Glioblastoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gold Coast University Hospital
  • Royal Adelaide HospitalRecruiting
  • Olivia Newton John Cancer Research Institute/Austin HealthRecruiting
  • Institut für Nuklearmedizin und EndokrinologieRecruiting
  • UNMC UtrechtRecruiting
  • Mercy HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

131I-TLX101 + standard of care

Arm Description

Outcomes

Primary Outcome Measures

Incidence rate and the grade (severity) of DLTs
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.
Safety, tolerability and RP2D
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.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2022
Last Updated
July 17, 2023
Sponsor
Telix International Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05450744
Brief Title
131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)
Acronym
IPAX-2
Official Title
A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telix International Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplastic Disease, Glioblastoma, Glioblastoma Multiforme
Keywords
Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
3+3 ascending dose
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
131I-TLX101 + standard of care
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
131I-IPA
Other Intervention Name(s)
18F-FET
Intervention Description
131I-IPA: injection/solution administrated intravenously via infusion in ascending doses 18F-FET: injection/solution administrated intravenously
Primary Outcome Measure Information:
Title
Incidence rate and the grade (severity) of DLTs
Description
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.
Time Frame
8 weeks from the first dose of IMP until discharge from the second dosem, up to 62 weeks.
Title
Safety, tolerability and RP2D
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Understand and voluntarily sign the informed consent form prior to any study related procedure and/or assessments being conducted. Are Male or Female, and aged 18-65 years of age inclusive, at the time of signing the informed consent. Have histologically confirmed intracranial glioblastoma (per WHO 2021 definition) following surgical resection. Tumours primarily localised in the infratentorial compartment will be excluded. Have had prior surgery for glioblastoma, but no systemic therapy or radiation therapy for GBM. Have a Karnofsky Performance Status ≥70. Plan to begin chemoradiation therapy 3-6 weeks after surgical resection with Stupp regimen. 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 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). 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. Agree to practice adequate precautions to prevent pregnancy to avoid potential problems associated with radiation exposure to the unborn child. Females must have a negative pregnancy test at screening and on dosing day, must not be lactating. Exclusion Criteria: Are unable to provide signed informed consent Have had prior treatment for glioma, excluding surgery. Are unable to undergo contrast-enhanced MRI. Intend to be treated with tumor-treating fields prior to progression. 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. Have a known history of allergy TMZ, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies. Have haemostaseologic conditions, precluding catheterisation or invasive procedures. Have phenylketonuria 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. Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 3 weeks of administration of study treatment except surgery on primary tumour. Pregnant, breastfeeding or planning to get pregnant during the duration of the study. 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. 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. Have concurrent malignancies unless the patient has been disease-free without intervention for at least 2 years. Have taken growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment. Have serious, non-healing wound, ulcer, or bone fracture. Have a requirement of concurrent use of other anti-cancer treatments or agents other than study medication. Have received any other IMP within 90 days prior to the planned administration of study drug. Have uncontrolled Hashimoto's or Grave's disease Have on-going and unresolved Grade ≥ 1 AEs following surgical resection
Facility Information:
Facility Name
Gold Coast University Hospital
City
Gold Coast
State/Province
Queensland
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator, MD
Phone
(08) 7074 0000
Email
Health.CALHNResearchEthics@sa.gov.au
Facility Name
Olivia Newton John Cancer Research Institute/Austin Health
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator, MD
Phone
(03) 9496 5726
Email
enquiries@onjcri.org.au
Facility Name
Institut für Nuklearmedizin und Endokrinologie
City
Linz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Email
info@telixpharma.com
Facility Name
UNMC Utrecht
City
Utrecht
ZIP/Postal Code
3051
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
383180090
Email
info@telixpharma.com
Facility Name
Mercy Hospital
City
Auckland
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Email
info@telixpharma.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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