Corbus Announces Dosing Of First Patient In U.S. Phase 1 Clinical Trial Of Its Next Generation Nectin-4 Targeting ADC
Corbus Announces Dosing Of First Patient In U.S. Phase 1 Clinical Trial Of Its Next Generation Nectin-4 Targeting ADC
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Study enrolling patients with metastatic urothelial cancer (mUC) and other Nectin-4 enriched tumors
- Emerging clinical profile from CSPC's Phase 1 China study indicates differentiation from PADCEV
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研究招收了轉移性尿路上皮癌（muC）和其他富含 Nectin-4 的腫瘤患者
- CSPC中國1期研究的最新臨床概況表明與PADCEV有所區別
NORWOOD, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) ("Corbus" or the "Company"), a precision oncology company with a diversified portfolio, announced today the first patient in the U.S. has been dosed in the Phase 1 clinical trial of CRB-701 (SYS6002), a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4.
馬薩諸塞州諾伍德，2024年4月2日（GLOBE NEWSWIRE）——擁有多元化投資組合的精準腫瘤學公司Corbus Pharmicals Holdings, Inc.（納斯達克股票代碼：CRBP）（“Corbus” 或 “公司”）今天宣佈，針對Nectin-4的下一代抗體藥物偶聯物（ADC）CRB-701（SYS6002）的1期臨床試驗已爲美國首位患者服藥。
The Phase 1 portion of the open label study design (NCT06265727), being conducted in the U.S. and Europe, will evaluate the safety, efficacy and pharmacokinetics (PK) of CRB-701 in participants with advanced solid tumors associated with high Nectin-4 expression. The Phase 1 trial initiates with dose escalation followed by dose optimization and concludes with dose expansion to determine the recommended Phase 2 dose.
在美國和歐洲進行的開放標籤研究設計（NCT06265727）的1期部分將評估 CRB-701 對患有晚期實體瘤且與高Nectin-4表達相關的參與者的安全性、有效性和藥代動力學（PK）。1期試驗以劑量遞增開始，然後進行劑量優化，最後擴大劑量以確定推薦的2期劑量。
"The initiation of our clinical trial is a significant milestone for Corbus and builds on the encouraging CRB-701 data presented by our development partner CSPC Pharmaceutical Group at ASCO-GU 2024 from the phase 1 study in China," said Yuval Cohen, PhD. Chief Executive Office of Corbus. "Those data suggest CRB-701 has a differentiated PK and safety profile compared to PADCEV (enfortumab vedotin-ejfv) which could translate into meaningful clinical benefits for patients with mUC and other Nectin-4 positive solid tumors."
尤瓦爾·科恩博士說：“我們的臨床試驗的啓動對Corbus來說是一個重要的里程碑，它建立在我們的開發合作伙伴CSPC製藥集團在2024年ASCO-GU上從中國第一階段研究中提供的令人鼓舞的 CRB-701 數據的基礎上。”Corbus 首席執行官辦公室。“這些數據表明，與PADCEV（enfortumab vedotin-ejfv）相比，CRB-701 具有差異化的PK和安全性，這可能會爲mUC和其他 Nectin-4 陽性實體瘤患者帶來有意義的臨床益處。”
About CRB-701
CRB-701 (SYS6002) is a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The Nectin-4 ADC PADCEV (enfortumab vedotin-ejfv) is approved for use in late metastatic urothelial cancer and recently received an expanded label under an accelerated approval from the Food and Drug Administration for use in combination with KEYTRUDA for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
關於 CRB-701
CRB-701（SYS6002）是針對Nectin-4的下一代抗體藥物偶聯物（ADC），它含有位點特異性、可分解的連接物，同源藥物抗體比率爲2，使用MMAE作爲有效載荷。Nectin-4 是一種經臨床驗證的尿路上皮癌腫瘤相關抗原。Nectin-4 ADC PADCEV（enfortumab vedotin-ejfv）獲准用於晚期轉移性尿路上皮癌，最近獲得了美國食品藥品監督管理局的加速批准，擴大了標籤，可與KEYTRUDA聯合用於沒有資格接受含順鉑化療的局部晚期或轉移性尿路上皮癌患者。