Oncternal Announces First Patient Dosed In Fourth Cohort Of Phase 1/2 Study Of ONCT-534 For The Treatment Of R/R Metastatic Castration-Resistant Prostate Cancer
Oncternal Announces First Patient Dosed In Fourth Cohort Of Phase 1/2 Study Of ONCT-534 For The Treatment Of R/R Metastatic Castration-Resistant Prostate Cancer
Oncternal Therapeutics, Inc. (NASDAQ:ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the first patient has been dosed in the fourth cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). Patients in the fourth dosing cohort will receive ONCT-534, the company's dual-action androgen receptor inhibitor (DAARI), at a dose of 300 mg taken orally each day. The decision to proceed to this higher dose level was made by the study's Safety Review Committee (SRC) after reviewing data from the patients treated to date, including the third dose level of 160 mg ONCT-534 daily.
專注於開發新型腫瘤療法的臨床階段生物製藥公司Oncternal Therapeutics, Inc.（納斯達克股票代碼：ONCT）今天宣佈，在其 ONCT-534 的第四期1/2期研究中，第一位患者已服藥，該研究用於治療已復發或難以接受批准的雄激素受體途徑抑制劑（ARPI）的晚期前列腺癌患者。第四組給藥組中的患者將接受該公司的雙效雄激素受體抑制劑（DAARI），劑量爲每天口服 300 mg。ONCT-534繼續保持更高劑量水平的決定是由該研究的安全審查委員會（SRC）在審查了迄今爲止接受治療的患者的數據（包括每天 160 mg ONCT-534 的第三劑量水平）後做出的。
"Reaching the 300 mg dose level represents a significant milestone for our ONCT-534 program. The drug has been well tolerated so far, and based on preclinical analyses, we are optimistic that study participants are receiving doses of ONCT-534 that may be within the active dose range for antitumor activity," said Salim Yazji M.D., Chief Medical Officer at Oncternal Therapeutics. "We continue to see strong demand from investigators and patients to participate in the study and expect to continue enrolling at a brisk pace. We look forward to announcing initial efficacy and safety data from the study, which we expect will be at the end of this quarter."
“達到 300 毫克的劑量水平是我們 ONCT-534 計劃的重要里程碑。到目前爲止，該藥物的耐受性良好，根據臨床前分析，我們樂觀地認爲，研究參與者接受的 ONCT-534 劑量可能在抗腫瘤活性的活性劑量範圍內。” Oncternal Therapeutics首席醫學官薩利姆·亞茲吉醫學博士說。“我們繼續看到研究人員和患者對參與這項研究的強勁需求，並預計將繼續快速入學。我們期待公佈該研究的初步療效和安全性數據，我們預計將在本季度末公佈。”
About Study ONCT-534-101
Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in patients with mCRPC who have relapsed or are refractory to approved ARPIs including enzalutamide, abiraterone, apalutamide, and darolutamide. After the safety and tolerability and preliminary antitumor activity of ONCT-534 have been assessed in Phase 1, Phase 2 will commence to further evaluate the safety and preliminary antitumor activity of ONCT-534 to support selecting an optimal dose.
關於 ONCT-534-101 研究
ONCT-534-101 研究是一項 1/2 期、單臂、開放標籤、多中心研究，旨在評估 ONCT-534 對已復發或對恩扎魯胺、阿比特龍、阿帕魯他胺和達洛他胺等批准的 ARPI 不耐藥的 mcRPC 患者的安全性和耐受性、藥代動力學和初步抗腫瘤活性。在 1 期評估 ONCT-534 的安全性和耐受性以及初步抗腫瘤活性後，第 2 階段將開始進一步評估 ONCT-534 的安全性和初步抗腫瘤活性，以支持選擇最佳劑量。
譯文內容由第三人軟體翻譯。