Investing News NetworkJuly 09, 2024Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce the therapeutic dosing of the first patient in its Phase 1 clinical trial of RAD 204, a proprietary nanobody which targets Programmed death-ligand 1 (PD-L1)-positive expression in Non-Small Cell Lung Cancer (NSCLC), the most common type of lung cancer.

投资新闻网2024年7月9日Radiopharm Theranostics（ASX:RAD，“Radiopharm”或“公司”）是一家临床阶段的生物制药公司，专注于为高度未满足的医疗需求领域开发创新的肿瘤放射性药物，很高兴宣布在其RAD 204的1期临床试验中对第一名患者进行治疗剂量，RAD 204是一种专有的纳米体，其靶向非小细胞肺癌（NSCLC）中程序性死亡配体1（PD-L1）阳性表达，非小细胞肺癌是最常见的肺癌类型。

First patient dosed with RAD 204 (PD-L1 nanobody) in a Phase 1 therapeutic trial at Wollongong Hospital, New South Wales.Phase 11 First-In-Human study designed to assess safety and tolerability of 177Lu-RAD204 in PD-L1-positive individuals with metastatic Non-Small Cell Lung Cancer (NSCLC).16 patients previously dosed in Phase 1 diagnostic study demonstrated safety and effective biodistribution, and validate the strong potential for 177Lu-RAD204 for the treatment of advanced NSCLC.First patient dosed with RAD 204 marks a significant milestone in Radiopharm’s commitment to developing transformative oncology radiotherapeutics.

在新南威尔士州卧龙岗医院的一期治疗试验中，第一名患者服用了RAD 204（PD-L1纳米抗体）。第11阶段首次人体研究旨在评估177Lu-RAD204在PD-L1阳性转移性非小细胞肺癌（NSCLC）患者中的安全性和耐受性[16]。先前在1期诊断研究中服用的患者表现出安全性和有效的生物分布，并验证了177Lu-RAD204治疗晚期NSCLC的巨大潜力。第一位服用RAD 204的患者标志着Radiopharm致力于开发变革性肿瘤放射治疗学的重要里程碑。

The open-label Phase 1 study, entitled “Study of the Safety and Tolerability of 177Lu-RAD 204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients with Metastatic Non-small Cell Lung Cancer”, is a First-In-Human dose escalation trial of 177Lu-RAD 2041, and is designed to evaluate the safety and preliminary efficacy of this novel radiotherapeutic in eligible individuals with advanced NSCLC.

这项开放标签的第一阶段研究题为“177Lu-RAD 204（一种针对转移性非小细胞肺癌患者程序性细胞死亡配体1的Lutetium-177放射性标记单结构域抗体）的安全性和耐受性研究”，是177Lu-RAD 2041的首次人体剂量递增试验，旨在评估这种新型放射治疗剂在符合条件的晚期非小细胞肺癌患者中的安全性和初步疗效。

Previously published2 Phase I data of 16 NSCLC patients imaged with RAD 204 have demonstrated that the diagnostic is safe and associated with acceptable dosimetry.The study is currently being conducted .

先前公布的用RAD 204成像的16名NSCLC患者的2期I期数据表明，该诊断是安全的，并且与可接受的剂量测定相关。目前正在进行这项研究。