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Nanobiotix Establishes Recommended Dose For Registrational Study Of Head & Neck Combo Therapy Trial

Nanobiotix Establishes Recommended Dose For Registrational Study Of Head & Neck Combo Therapy Trial

Nanobiotix確立頭頸聯合治療試驗註冊研究的推薦劑量
Benzinga Real-time News ·  2022/09/22 07:24
  • Nanobiotix (NASDAQ:NBTX) determined the recommended phase 2 dose (RP2D) of the NBTXR3 combo regime for inoperable locoregional recurrent or recurrent and metastatic head and neck squamous cell carcinoma that is resistant to prior immunotherapy.
  • The combo includes NBTXR3 plus Merck & Co Inc's (NYSE:MRK) Keytruda pembrolizumab or Bristol Myers Squibb Co's (NYSE:BMY) Opdivo (nivolumab).
  • The combined dose escalation and dose expansion parts of Study 1100 are expected to enroll up to 141 patients.
  • Related: Nanobiotix's Radiotherapy Combo Therapy Shows Boosted Anti-Tumor Activity In Preclinical Studies.
  • The complete dose escalation part enrolled 29 patients in three cohorts. Based on the study's results, the RP2D for all three cohorts was determined to be 33% of gross tumor volume.
  • Nanobiotix has amended the ongoing expansion phase of Study 1100. The amended dose expansion part also has three cohorts. However, the cohorts have been re-designed further to explore NBTXR3 plus anti-PD-1 in several immunotherapy-eligible indications, focusing on patients that are either naïve or resistant to prior immunotherapy.
  • The company expects to provide updated clinical data from Study 1100 in Q4 2022. The registrational phase 3 protocol submission is expected in Q1 2023, followed by modification of the study design.
  • Price Action: NBTX shares closed at $4.04 on Wednesday.
  • 納米生物納斯達克(美國國家癌症研究所代碼：NBTX)確定了NBTXR3聯合方案對先前免疫療法耐藥的無法手術的局部區域復發或復發及轉移性頭頸部鱗狀細胞癌的推薦2期劑量(RP2D)。
  • 組合包括NBTXR3 PLUS默沙東(紐約證券交易所股票代碼：MRK)Keytruda pembrolizumab或百時美施貴寶公司(紐約證券交易所代碼：BMY)Opdivo(Nivolumab)。
  • 1100號研究的劑量遞增和劑量擴大的綜合部分預計將納入多達141名患者。
  • 相關： Nanobiotix的放射治療聯合療法在臨牀前研究中顯示出增強的抗腫瘤活性.
  • 完全劑量遞增部分納入了三個隊列中的29名患者。根據這項研究的結果，所有三個隊列的RP2D被確定為大體腫瘤體積的33%。
  • Nanobiotix已經修改了1100號研究的正在進行的擴展階段。修改後的劑量擴展部分也有三個隊列。然而，這些隊列已被重新設計，以進一步探索NBTXR3加抗PD-1在幾種免疫治療合格適應症中的應用，重點關注NAÏVE或對先前免疫治療耐藥的患者。
  • 該公司預計將在2022年第四季度提供1100號研究的最新臨牀數據。註冊階段3方案預計將於2023年第一季度提交，隨後將修改研究設計。
  • 價格行動：NBTX股價週三收於4.04美元。
声明：本內容僅用作提供資訊及教育之目的，不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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