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;
Parallel
177Lu-TLX250
Radiation3 infusions of 177Lu-TLX250 at 8-week intervals or 6 infusions 177Lu-TLX250 at 4-week intervals
Dose Optimization -safety and tolerability
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.
Efficacy- median mPFS
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).
Monitoring OS (Overall Survival)
Time from the date of randomization to death from any cause
Monitoring ORR (Objective Response Rate)
Proportion of participants achieving confirmed objective response rate (ORR), i.e., complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by a blinded independent central review (BICR)
Monitoring DoR (Duration of Response)
Time from the first documentation of objective response, i.e., complete response (CR) or partial response (PR) to the first documentation of disease progression or death due to any cause as assessed by blinded independent central review (BICR)
Monitoring DCR (Disease control Rate)
The proportion of participants achieving confirmed objective response, i.e., complete response (CR), partial response (PR), or stable disease (SD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR)
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Telix Pharmaceuticals (Innovations) Pty Limited
Lead sponsor
Medpace, Inc.
Collaborator
