Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
177Lu-TLX250 and Peposertib · 1 trial · 3 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Histologically confirmed advanced or metastatic solid tumor that has progressed on or during/after recognized standard of care therapies and are not eligible for resection, or patients that are not eligible or not consenting to recognized standard of care therapies. * At least...
177Lu-TLX250 is an investigational radiopharmaceutical being studied for use in advanced clear cell renal cell carcinoma (ccRCC) and other carbonic anhydrase IX-expressing solid tumors in adults. It is currently in clinical development and has not been approved by regulatory authorities.
177Lu-TLX250 is being developed by Telix Pharmaceuticals Limited, a biopharmaceutical company listed on the Australian Securities Exchange under the ticker TLX. The company is conducting clinical trials of this investigational agent in oncology indications.
177Lu-TLX250 is in Phase 3 clinical development for advanced relapsed or recurrent clear cell renal cell carcinoma (ccRCC). A Phase 1 trial is also recruiting to evaluate the drug in combination with peposertib for carbonic anhydrase IX-expressing solid tumors.
177Lu-TLX250 is being studied in two recruiting trials. NCT07197580 is a Phase 3 study in advanced relapsed or recurrent ccRCC with 40 participants. NCT05868174 is a Phase 1 study combining 177Lu-TLX250 with peposertib in patients with carbonic anhydrase IX-expressing solid tumors, enrolling 36 participants.
177Lu-TLX250 and peposertib are different agents being studied together in a clinical trial. 177Lu-TLX250 is a radiopharmaceutical targeting carbonic anhydrase IX, while peposertib is a separate drug used in combination. They are not the same compound.
177Lu-TLX250 targets carbonic anhydrase IX, an antigen expressed on certain solid tumors. The drug is being evaluated in cancers that express this target, including clear cell renal cell carcinoma (ccRCC) and other advanced solid tumors.