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OncoMatch/Clinical Trials/NCT05450744

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

Is NCT05450744 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies 131I-IPA for neoplastic disease.

Phase 1RecruitingTelix Pharmaceuticals (Innovations) Pty LimitedNCT05450744Data as of May 2026

Treatment: 131I-IPAThis 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.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Must have received: surgery — glioblastoma

Have had prior surgery for glioblastoma

Cannot have received: systemic therapy

no systemic therapy or radiation therapy for GBM

Cannot have received: radiation therapy

no systemic therapy or radiation therapy for GBM

Cannot have received: any treatment for glioma, excluding surgery

Have had prior treatment for glioma, excluding surgery

Lab requirements

Blood counts

leukocytes ≥3,000/ml; absolute neutrophil count ≥1500/ml; platelets ≥100,000/ml; haemoglobin ≥9g/dl

Kidney function

serum/plasma creatinine ≤1.5×uln or creatinine clearance ≥50 ml/min

Liver function

total bilirubin ≤1.5×uln (≤3×uln for gilbert's syndrome); alt or ast ≤2.5×uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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