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Frequency and severity of treatment emergent adverse events (TEAEs), Dose Limiting Toxicities (DLTs), serious adverse events (SAEs) and adverse events of special interest (AESIs). Preliminary efficacy response across all cycles in Phase 1.
Evaluate dose levels in Phase 1 escalating group design to identify the MTD and the administered activity to be used in the expansion cohort
Radiation absorbed dose estimates for selected normal tissues. Analysis of radioactive blood samples for select timepoints.
Objective response rate (ORR), defined as the proportion of patient with a complete response (CR) or partial response (PR), per RECISTv1.1.
Duration of Response (DOR), defined as the duration of time from first date of observed response (CR or PR), to first date of disease progression of death from any cause.
Frequency and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)s
Change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLC-C30 Version 3)
Clearance, area under the concentration time curve over 4 hours (AUC0 4) and to the last measurable concentration (AUC0 last), for [Ac 225]RTX 2358.
(Cmax) for [Ac 225]RTX 2358
Half life for [Ac 225]RTX 2358
Disease control rate (DCR), defined as the percentage of patients with CR, PR, or stable disease (SD)