Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TLX250-Tx, 177Lu girentuximab tetraxetan
177Lu-TLX250 · 2 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 clear cell renal cell carcinoma (ccRCC) and other carbonic anhydrase IX-expressing solid tumors. It is a small molecule radiopharmaceutical conjugate that is currently in clinical development and has not been approved by the FDA.
177Lu-TLX250 is being studied for the treatment of advanced relapsed or recurrent clear cell renal cell carcinoma (ccRCC), a type of kidney cancer. It is also being evaluated in adult patients with advanced solid tumors that express carbonic anhydrase IX. The drug remains investigational and is not yet approved for any indication.
177Lu-TLX250 is developed by Telix Pharmaceuticals Limited, an Australian radiopharmaceutical company that trades under the ticker TLX. Telix is sponsoring the clinical development program for this asset across renal cell carcinoma and other carbonic anhydrase IX-expressing solid tumors.
177Lu-TLX250 is in Phase 1 and Phase 3 clinical development. A Phase 1 trial is evaluating the combination of 177Lu-TLX250 and peposertib in patients with carbonic anhydrase IX-expressing solid tumors, while a Phase 3 study is assessing the drug in advanced relapsed or recurrent ccRCC. The drug is investigational and not FDA approved.
177Lu-TLX250 is being evaluated in two recruiting clinical trials. NCT07197580 is a Phase 3 study assessing safety and efficacy in advanced relapsed or recurrent ccRCC, enrolling 40 patients in Australia. NCT05868174 is a Phase 1 study of 177Lu-TLX250 combined with peposertib in patients with carbonic anhydrase IX-expressing solid tumors, enrolling 36 patients in Australia.
No. 177Lu-TLX250 and peposertib are two distinct agents. 177Lu-TLX250 is the radiopharmaceutical being developed by Telix Pharmaceuticals, while peposertib is a separate drug being studied in combination with 177Lu-TLX250 in a Phase 1 trial for carbonic anhydrase IX-expressing solid tumors.