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Also known as 177Lu-TLX250 and Peposertib
177Lu-TLX250 · 1 trial · 6 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).
| 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 |
| Name | Type | Description |
|---|---|---|
| 177Lu-TLX250 | RADIATION | 3 infusions of 177Lu-TLX250 at 8-week intervals or 6 infusions 177Lu-TLX250 at 4-week intervals |
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 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.