Sutro Biopharma Announces First Patient Dosed in the Dose-Expansion Study of STRO-002 in Patients with Ovarian Cancer
Sutro Biopharma Announces First Patient Dosed in the Dose-Expansion Study of STRO-002 in Patients with Ovarian Cancer
Sutro Biopharma, Inc. (NASDAQ:STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, today announced the dosing of the first patient in the dose-expansion cohort of the Phase 1 STRO-002 study. STRO-002 is an internally developed, folate receptor alpha (FolRα) targeting antibody-drug conjugate (ADC) for the potential treatment of ovarian cancer. The dose-expansion cohort will assess the efficacy, safety and tolerability of STRO-002 at 4.3 and 5.2 mg/kg, given every 3 weeks in patients with ovarian cancer. The dose-expansion cohort for FolRα-selected endometrial cancer is planned for later this year.
Sutro Biophma，Inc.(納斯達克：Stro)，一家專注於應用精確蛋白質工程和合理設計來創造下一代癌症和自身免疫療法的臨牀階段藥物發現、開發和製造公司，今天宣佈對第1階段Stro-002研究的劑量擴展隊列中的第一名患者進行劑量分配。STRO-002是一種國內開發的葉酸受體α(FolR-α)，靶向抗體-藥物結合物，可用於卵巢癌的潛在治療。劑量擴展隊列將評估每3周給卵巢癌患者4.3和5.2 mg/kg的Stro-002的有效性、安全性和耐受性。FolRα選擇的子宮內膜癌的劑量擴展隊列計劃在今年晚些時候進行。
"We are pleased to advance the clinical development of STRO-002 into dose-expansion studies. Results from our STRO-002 dose escalation in a heavily pre-treated ovarian cancer patient population demonstrated improved outcomes in RECIST response and duration of response," said Dr. Arturo Molina, Chief Medical Officer of Sutro Biopharma. "Sutro plans to expand the study to approximately 35 clinical sites in the U.S. and Europe. We are hopeful that the dose-expansion study will validate the preliminary signs of efficacy we have seen in dose-escalation and provide valuable data on the treatment paradigm and patient population that will benefit from treatment, bringing us one step closer to offering an important new potential treatment option to ovarian cancer patients."
Sutro Biophma公司首席醫療官阿圖羅·莫利納博士説：“我們很高興將Stro-002的臨牀開發推進到劑量擴展研究中。我們在經過大量預處理的卵巢癌患者羣體中增加Stro-002劑量的結果表明，RECIST反應和反應持續時間都有所改善，”Sutro Biophma的首席醫療官阿圖羅·莫利納博士説。Sutro計劃將這項研究擴大到美國和歐洲的大約35個臨牀地點。我們希望，劑量擴大研究將驗證我們在劑量遞增中看到的初步療效跡象，並提供有關治療範例和將從治療中受益的患者羣體的寶貴數據，使我們朝着向卵巢癌患者提供一種重要的潛在治療選擇又近了一步。“
Dr. Lainie Martin, Leader of Gynecology/Oncology Program at Hospital of the University of Pennsylvania and an investigator on the STRO-002-GM1 study, said, "STRO-002 continues to be well-tolerated and we have observed encouraging preliminary activity in patients with advanced platinum-resistant and refractory ovarian cancer. We are excited to be part of the STRO-002-GM1 dose-expansion study and to provide additional clinical data to show the potential of this therapeutic for ovarian patients with limited treatment options."
賓夕法尼亞大學醫院婦科/腫瘤學項目負責人、Stro-002-GM1研究的調查員Lainie Martin博士説：“Stro-002仍然耐受性良好，我們觀察到晚期鉑耐藥和難治性卵巢癌患者的初步活動令人鼓舞。我們很高興能成為Stro-002-GM1劑量擴展研究的一部分，並提供更多的臨牀數據來展示這種療法對治療有限的卵巢患者的潛力。我們很高興能成為Stro-002-GM1劑量擴展研究的一部分，並提供更多的臨牀數據來展示這種療法對有限治療的卵巢患者的潛力
The dose-expansion study includes two patient cohorts, advanced epithelial ovarian cancer and endometrial cancer. The ovarian cancer cohort currently enrolling includes patients with platinum resistant disease and have received 1-3 prior regimens or platinum sensitive patients that have received 2-3 prior treatment regimens. Patients in the dose-expansion cohort of the STRO-002-GM1 Phase 1 study will be randomized 1:1 and treated with either 4.3 or 5.2 mg/kg STRO-002 intravenously once every three-weeks. Patients will not be pre-selected for FolRα expression and fresh or archival tumor tissue sample is required for immunohistochemistry (IHC) analysis of FolRα expression.
劑量擴張研究包括兩個患者隊列，晚期上皮性卵巢癌和子宮內膜癌。目前招募的卵巢癌隊列包括對鉑耐藥的疾病患者，並且已經接受過1-3個先前的治療方案，或者接受過2-3個先前治療方案的鉑敏感患者。在STRO-002-GM1第一階段研究的劑量擴展隊列中的患者將被隨機分為1：1，每三週靜脈注射一次4.3或5.2毫克/公斤的STRO-002。患者不會被預先選擇進行FolRα的表達，需要新鮮或存檔的腫瘤組織樣本進行FolRα表達的免疫組織化學分析。
Additional information on the study can be found at: https://clinicaltrials.gov/ct2/show/NCT03748186
有關這項研究的更多信息，請訪問：Https://clinicaltrials.gov/ct2/show/NCT03748186
About the Phase 1 Trial of STRO-002 in Ovarian Cancer
STRO-002-GM1, the Phase 1 open-label, multicenter, dose escalation trial with dose expansion of STRO–002, has completed enrollment. Follow-up is ongoing and will continue to evaluate the safety, tolerability, and preliminary anti-tumor activity of STRO-002 in adults with advanced epithelial ovarian cancer, including fallopian and primary peritoneal cancer. The trial is registered with clinicaltrials.gov identifier NCT03748186. Sutro discovered, developed and manufactures STRO-002 using its proprietary XpressCF® cell-free protein synthesis and XpressCF+™ site-specific conjugation technologies.
關於Stro-002治療卵巢癌的一期試驗STRO-002-GM1，一期開放標籤、多中心、劑量遞增試驗，劑量擴展為STRO-002，已經完成登記。後續研究正在進行中，並將繼續評估Stro-002在患有晚期上皮性卵巢癌(包括輸卵管癌和原發性腹膜癌)的成人患者中的安全性、耐受性和初步抗腫瘤活性。該試驗註冊了Clinicaltrials.gov標識符NCT03748186。Sutro利用其專有的XpressCF®無細胞蛋白質合成和XpressCF+™位點特定結合技術發現、開發和製造STRO-002。
譯文內容由第三人軟體翻譯。