Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05450744
Other study ID # 131I-TLX-101-002 (IPAX-2)
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 1, 2023
Est. completion date June 2025

Study information

Verified date July 2023
Source Telix International Pty Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Gold Coast University Hospital Gold Coast Queensland
Australia Olivia Newton John Cancer Research Institute/Austin Health Melbourne Victoria
Austria Institut für Nuklearmedizin und Endokrinologie Linz
Netherlands UNMC Utrecht Utrecht
New Zealand Mercy Hospital Auckland

Sponsors (1)

Lead Sponsor Collaborator
Telix International Pty Ltd

Countries where clinical trial is conducted

Australia,  Austria,  Netherlands,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 8 weeks from the first dose of IMP until discharge from the second dosem, up to 62 weeks.
Primary 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. 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.
See also
  Status Clinical Trial Phase
Recruiting NCT05664243 - A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma Phase 1/Phase 2
Completed NCT02768389 - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma Early Phase 1
Recruiting NCT05635734 - Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma Phase 1/Phase 2
Completed NCT03679754 - Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102 Phase 1
Completed NCT01250470 - Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma Phase 1
Terminated NCT03927222 - Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma Phase 2
Recruiting NCT03897491 - PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma Phase 2
Active, not recruiting NCT03587038 - OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma Phase 1
Completed NCT01922076 - Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas Phase 1
Recruiting NCT04391062 - Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma Phase 2
Active, not recruiting NCT03661723 - Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma Phase 2
Active, not recruiting NCT02655601 - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 Phase 2
Completed NCT02206230 - Trial of Hypofractionated Radiation Therapy for Glioblastoma Phase 2
Completed NCT03493932 - Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade Phase 1
Terminated NCT02709889 - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06058988 - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Phase 2
Completed NCT03018288 - Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM) Phase 2
Not yet recruiting NCT04552977 - A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma Phase 2
Withdrawn NCT03980249 - Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells Early Phase 1
Withdrawn NCT02876003 - Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma Phase 2