Telix Pharmaceuticals (Innovations) Pty Limited
Multicenter Phase 2A study of 177Lu-TLX250 in adult participants with CAIX-expressing advanced, relapsed or recurrent clear cell renal cell carcinoma (ccRCC). Part 1 will evaluate two dosing regimens to determine the recommended Phase 3 dose (RP3D).
This is an open-label, multi-center 2A study evaluating the safety and efficacy of 177Lu-TLX250, a CAIX-targeting radioligand therapy, in adult participants with advanced, relapsed or recurrent clear cell renal cell carcinoma (ccRCC). The objective is to determine the recommended Phase 3 dose (RP3D) for use in Phase 3 study.
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 cell component per American Joint Committee on Cancer Staging Manual (Edge SB et al., 2017), with or without sarcomatoid features; * have received at least 2 and no more than 3 prior lines of systemic therapies for locally advanced or metastatic ccRCC including a PD-1/PD-L1 inhibitor (at least 2 ad…
3 infusions of 177Lu-TLX250 at 8-week intervals or 6 infusions 177Lu-TLX250 at 4-week intervals