Repare Begins Clinical Trial Combining RP-3467 and PARP Inhibitor Olaparib to Fight Advanced Cancers
Repare Begins Clinical Trial Combining RP-3467 and PARP Inhibitor Olaparib to Fight Advanced Cancers
Repare Therapeutics Inc. ("Repare" or the "Company") (NASDAQ:RPTX), a leading clinical-stage precision oncology company, today announced the first patient has been dosed in the Company's Phase 1 (POLAR) clinical trial evaluating RP-3467, a Polθ ATPase inhibitor, alone and in combination with the poly-ADP ribose polymerase (PARP) inhibitor, olaparib. RP-3467 is Repare's fourth clinical program.
Repare Therapeutics Inc.("Repare"或"公司")(納斯達克股票代碼:RPTX)是一家領先的臨床階段精準腫瘤醫學公司,今天宣佈公司的第一名患者已在公司的第 1 階段(POLAR)臨床試驗中接受了 RP-3467 號(一種 Polθ ATPase 抑制劑)和拓普利衛(一種聚 ADP 核糖聚合酶(PARP)抑制劑)聯合用藥評估的劑量。RP-3467 是 Repare 的第四個臨床項目。
"RP-3467, our potential best-in-class Polθ ATPase inhibitor, has demonstrated highly compelling preclinical results, including complete and durable tumor regressions in combination with olaparib, the leading PARP inhibitor, with no additive toxicities. This combination is designed to meaningfully improve patient outcomes by mitigating PARP inhibitor resistance, a significant area of high unmet medical need," said Maria Koehler, MD, PhD, Executive Vice President and Chief Medical Officer of Repare. "In addition, Repare's previously reported data established the potential for RP-3467 to improve efficacy and limit toxicity in combination with radioligand therapy and chemotherapy-bearing antibody drug conjugates (ADCs), and we look forward to exploring those areas."
"RP-3467,我們潛在的一流 Polθ ATPase 抑制劑,展示了極具說服力的臨床前研究結果,包括與巖帕利博(PARP 抑制劑的佼佼者)聯合使用時完全和持續的腫瘤退縮,而且沒有附加毒性。該組合旨在通過減輕 PARP 抑制劑的抗藥性(這是一個高度醫療需求未滿足的領域)顯著改善患者結局,"Repare 的執行副總裁兼首席醫療官Maria Koehler博士說。"此外,Repare 曾經公佈的數據證實了 RP-3467 可能提高療效,並限制與放射配體療法和化療-免疫藥物複合物(ADCs)聯合應用時的毒性,我們期待探索這些領域。"
The POLAR clinical trial (NCT06560632) is a multicenter, open-label, dose-escalation Phase 1 clinical trial to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3467 alone or in combination with the PARP inhibitor, olaparib, in adults with molecularly selected advanced solid tumors. The study is expected to enroll approximately 52 patients with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma. The primary objectives of the study are to assess the safety and tolerability of RP-3467 alone and in combination with olaparib, and to define a preliminary recommended Phase 2 dose of RP-3467 in combination with olaparib.
POLAR 臨床試驗(NCT06560632)是一項多中心、開放標籤、劑量遞增的第 1 階段臨床試驗,旨在研究 RP-3467 單獨使用或與 PARP 抑制劑拓普利衛聯合使用對分子篩選的晚期實體瘤的安全性、藥代動力學、藥效動力學和初步臨床活性。該研究預計將招募大約 52 名患有局部晚期或轉移性上皮性卵巢癌、轉移性乳腺癌、轉移性去勢抵抗性前列腺癌或胰腺腺癌的成年患者。該研究的主要目標是評估 RP-3467 單獨使用和與拓普利衛聯合使用的安全性和耐受性,並確定 RP-3467 與拓普利衛聯合使用的預定義推薦的第 2 階段劑量。