2023 World Conference on Lung Cancer (Posters)-P2.16. RYZ101 + Carboplatin + Etoposide + Atezolizumab in Somatostatin Receptor Expressing Extensive-Stage Small-Cell Lung Cancer

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This document discusses a phase 1b clinical trial evaluating the safety and preliminary effectiveness of RYZ101, a first-in-class alpha-emitting radiopharmaceutical, in combination with standard of care (SoC) therapy for extensive-stage small-cell lung cancer (ES-SCLC) patients who express somatostatin receptor subtype 2 (SSTR2).<br /><br />ES-SCLC, a highly aggressive form of lung cancer, currently has poor outcomes despite its initial sensitivity to radiotherapy and chemotherapy. Approximately half of ES-SCLC tumors express SSTR2, which is associated with a worse prognosis. RYZ101, an alpha-emitting radiopharmaceutical, has a shorter path length and higher linear energy transfer than beta-particles, potentially leading to higher cancer cell kill rates and less damage to healthy tissues.<br /><br />The trial is a single-arm, open-label study that aims to determine the safety, preliminary antitumor activity, and pharmacokinetics of RYZ101 in combination with SoC therapy comprising carboplatin, etoposide, and atezolizumab. The study includes adult patients with previously untreated SSTR ES-SCLC, adequate organ function, and SSTR PET imaging-positive disease. The patients may receive up to one cycle of SoC chemoimmunotherapy before or during screening.<br /><br />The study design involves dose escalation and dose expansion phases, with RYZ101 administered intravenously at different levels in conjunction with the SoC therapy. The primary endpoints include determining the recommended phase 2 dose of RYZ101 and assessing the incidence of dose-limiting toxicities during the first 42 days of treatment. Safety, preliminary antitumor activity, and pharmacokinetics are also evaluated as secondary objectives.<br /><br />The trial is actively screening and enrolling patients at multiple sites in the United States and Puerto Rico. The study will assess the durability of objective response rates, as well as other efficacy endpoints such as overall survival and progression-free survival. Pharmacokinetic assessments and exploratory analyses of biomarkers associated with treatment efficacy and safety are also being conducted.<br /><br />In conclusion, this phase 1b clinical trial aims to evaluate the safety and preliminary effectiveness of RYZ101 in combination with SoC therapy for SSTR ES-SCLC patients. The study is ongoing, with the goal of identifying an appropriate dosage and assessing the potential benefits of this novel treatment approach.

Asset Subtitle

Claire Mulvey

Meta Tag

Speaker Claire Mulvey

Topic SCLC & Neuroendocrine Tumors: Trials in Progress

Keywords

phase 1b clinical trial

RYZ101

alpha-emitting radiopharmaceutical

extensive-stage small-cell lung cancer

somatostatin receptor subtype 2

standard of care therapy

safety

preliminary effectiveness

dose escalation

dose expansion