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).
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;
Sequential
177Lu-TLX250
Drug3 infusions of 177Lu-TLX250 at 8-week intervals or 6 infusions 177Lu-TLX250 at 4-week intervals
Dose Optimization -safety and tolerability
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.
Evaluate blood radioactive PK parameter- Cmax (maximum plasma concentration)
Gamma-counting blood radioactivity will be used to derive this pharmacokinetics parameter
Evaluate blood radioactive PK parameter- AUCinf (area under blood concentration time curve from zero to infinity)
Gamma-counting blood radioactivity will be used to derive this pharmacokinetics parameter.
Evaluate blood radioactive PK parameter- t1/2 (Terminal half-life)
Gamma-counting blood radioactivity will be used to derive this pharmacokinetics parameter.
Evaluate blood radioactive PK parameter- CL (Clearance)
Gamma-counting blood radioactivity will be used to derive this pharmacokinetics parameter.
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