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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 (Jun 2026). This Phase 1 trial studies 131I-IPA for neoplastic disease.

Phase 1RecruitingTelix Pharmaceuticals (Innovations) Pty LimitedNCT05450744Data as of Jun 2026Location: Australia · Austria · Netherlands

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

Treatments studied

Other

131I-IPA

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.

Frequently asked questions

Is NCT05450744 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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Related pages

Glioblastoma trials