A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 years or older, 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:

‣ 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.

Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Gold Coast University Hospital
RECRUITING
Gold Coast
Olivia Newton John Cancer Research Institute/Austin Health
RECRUITING
Melbourne
Royal North Shore Hospital
RECRUITING
Sydney
Austria
Institut für Nuklearmedizin und Endokrinologie
RECRUITING
Linz
Netherlands
UNMC Utrecht
RECRUITING
Utrecht
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 12
Treatments
Experimental: 131I-TLX101 + standard of care
Sponsors
Leads: Telix Pharmaceuticals (Innovations) Pty Limited

This content was sourced from clinicaltrials.gov