Multicenter Phase 3 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). Part 2 will compare 177Lu-TLX250 with investigator's choice of monotherapy aligned with Australian standard-of-care.
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 administrations) and a VEGF/VEGFR-targeting agent (including TKI or mAb) in sequence or in combination;
visceral metastatic lesions that are ≥ 1 cm that have a CAIX TLR < 1;
lytic bone metastatic lesions with a soft tissue component of at least 1 cm with a TLR < 1; and/or
at least one metastatic lymph node lesion with short axis ≥ 2.5 cm with a TLR <1;
received prior 177Lu-TLX250 therapy, any other radioligand therapy, or any prior CAIX-targeting therapy;
Telix Pharmaceuticals (Innovations) Pty Limited
Lead sponsor
Medpace, Inc.
Collaborator