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Also known as TLX250-Tx, 177Lu girentuximab tetraxetan
177Lu-TLX250 · 3 trials · 9 indications
Part 1 of the study is being done to identify the best dose to use for Part 2 of the study. Assessing adverse events of special interest (AESIs), incidence and severity of treatment-emergent adverse events (TEAEs) and 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.
Primary objective for Part 2 of the study and secondary objective for Part 1. Monitoring disease progression according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
Dose level toxicity evaluation using Partial Ordering Bayesian Logistic Regression Model Method (PO-BLRM)
Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the vital signs
Frequency of occurrence and severity of abnormal findings in the 12-lead ECG (ECG QT interval)
Assessment of AEs graded by the Common Terminology Criteria for Adverse Events (CTCAE) Criteria, Version 5.0
Quality of life ( in terms of their ability to care for themself, daily activity, and physical ability (walking, working) is to be evaluated using the ECOG Performance Scale.
| Arm | Type | Description |
|---|---|---|
| 1887MBq 177Lu-girentuximab tetraxetan | EXPERIMENTAL | 3 infusions of 1887 MBq 177Lu-TLX250 at 8-week intervals or 6 infusions of 1258 MBq 177Lu-TLX250 at 4-week intervals (fractionation of 3 doses of 2516 MBq) |
| 1258 MBq 177Lu-girentuximab tetraxetan | EXPERIMENTAL | 6 infusions of 1258 MBq 177Lu-TLX250 at 4-week intervals |
| 89Zr-TLX250, 177Lu-TLX250 and Peposertib | EXPERIMENTAL | Diagnostic test: A single IV administration of 37 Megabecquerel (+/- 10%) 89Zr-DFO-girentuximab, containing a mass dose of 10 mg of girentuximab, followed by a diagnostic scan Treatment test: A single IV administration that could be 1887 - 2516 or 3145 Megabecquerel (+/- 10%) 177Lu-DOTA-girentuximab,containing a mass dose of 10 mg of girentuximab, on Day 1 of each 84-day cycle and p.o. administration of that could be 100-150 or 200 mg Peposertib BID on days 4-21 of each 84-day cycle. |
| Name | Type | Description |
|---|---|---|
| 177Lu-TLX250 | RADIATION | 3 infusions of 177Lu-TLX250 at 8-week intervals or 6 infusions 177Lu-TLX250 at 4-week intervals |
| 89Zr-TLX250 | DIAGNOSTIC_TEST | Single IV administration followed by 89Zr-DFO-girentuximab PET/CT (or PET/MRI) scan at screening and approximately 8-10 weeks (±1 week) after Cycle 3 Day 1, as well as at the end of treatment visit (if feasible). The PET/CT should be obtained within 4-7 days after 89Zr-TLX250 administration |
| 177Lu-TLX250 and Peposertib | COMBINATION_PRODUCT | Dose escalation and de-escalation for the determination of the Maximum tolerated combination/ Recommended phase 2 dose. All subjects will receive 177Lu-TLX250 intravenously on day 1 and Peposertib BID on days 4-21 of each 84-day cycle. |
Inclusion Criteria: * be aged ≥ 18 years. * have provided written informed consent, dated and signed by the participant prior to any study-specific procedure; * have relapsed or recurrent, locally advanced, or metastatic RCC with histologically or cytologically confirmed diagnosis of RCC with clear...
177Lu-TLX250 is an investigational oncology therapy being developed by Telix Pharmaceuticals Limited for advanced solid tumors, including clear cell renal cell carcinoma (ccRCC). It is a small molecule radiopharmaceutical candidate studied in adult patients with relapsed or recurrent disease. It remains in clinical development and is not approved for commercial use.
177Lu-TLX250 is being studied in adults with advanced relapsed or recurrent clear cell renal cell carcinoma (ccRCC), a form of kidney cancer. Clinical trials are evaluating it in this patient population, including metastatic and recurrent renal cell cancer. It is investigational and has not been approved for the treatment of ccRCC.
Telix Pharmaceuticals Limited is developing 177Lu-TLX250. The company trades under the ticker TLX. Telix is sponsoring the clinical program evaluating the candidate across advanced solid tumors and clear cell renal cell carcinoma.
177Lu-TLX250 is in clinical development, with studies spanning Phase 1 through Phase 3. A Phase 3 trial in advanced relapsed or recurrent ccRCC is currently recruiting, and a Phase 2a dosing study is not yet recruiting. The candidate is investigational and has not been approved by the FDA.
177Lu-TLX250 is being evaluated in three registered studies. NCT07197580 is a recruiting Phase 3 trial in advanced relapsed or recurrent ccRCC in Australia. NCT07870746 is a Phase 2a dosing study in ccRCC in the United States. NCT05868174 is a recruiting Phase 1 trial combining 177Lu-TLX250 with Peposertib in carbonic anhydrase IX-expressing solid tumors in Australia.
No. 177Lu-TLX250 and Peposertib are separate agents. Peposertib is being studied in combination with 177Lu-TLX250 in a Phase 1 trial in patients with carbonic anhydrase IX-expressing solid tumors. The two are distinct compounds evaluated together, not alternative names for the same drug.