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.(纳斯达克：Stro)，一家专注于应用精确蛋白质工程和合理设计来创造下一代癌症和自身免疫疗法的临床阶段药物发现、开发和制造公司，今天宣布对第1阶段Stro-002研究的剂量扩展队列中的第一名患者进行剂量分配。STRO-002是一种国内开发的叶酸受体α(FolR-α)，靶向抗体-药物结合物，可用于卵巢癌的潜在治疗。剂量扩展队列将评估每3周给卵巢癌患者4.3和5.2 mg/kg的Stro-002的有效性、安全性和耐受性。FolRα选择的子宫内膜癌的剂量扩展队列计划在今年晚些时候进行。
"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公司首席医疗官阿图罗·莫利纳博士说：“我们很高兴将Stro-002的临床开发推进到剂量扩展研究中。我们在经过大量预处理的卵巢癌患者群体中增加Stro-002剂量的结果表明，RECIST反应和反应持续时间都有所改善，”Sutro Biophma的首席医疗官阿图罗·莫利纳博士说。Sutro计划将这项研究扩大到美国和欧洲的大约35个临床地点。我们希望，剂量扩大研究将验证我们在剂量递增中看到的初步疗效迹象，并提供有关治疗范例和将从治疗中受益的患者群体的宝贵数据，使我们朝着向卵巢癌患者提供一种重要的潜在治疗选择又近了一步。“
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."
宾夕法尼亚大学医院妇科/肿瘤学项目负责人、Stro-002-GM1研究的调查员Lainie Martin博士说：“Stro-002仍然耐受性良好，我们观察到晚期铂耐药和难治性卵巢癌患者的初步活动令人鼓舞。我们很高兴能成为Stro-002-GM1剂量扩展研究的一部分，并提供更多的临床数据来展示这种疗法对治疗有限的卵巢患者的潜力。我们很高兴能成为Stro-002-GM1剂量扩展研究的一部分，并提供更多的临床数据来展示这种疗法对有限治疗的卵巢患者的潜力
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.
剂量扩张研究包括两个患者队列，晚期上皮性卵巢癌和子宫内膜癌。目前招募的卵巢癌队列包括对铂耐药的疾病患者，并且已经接受过1-3个先前的治疗方案，或者接受过2-3个先前治疗方案的铂敏感患者。在STRO-002-GM1第一阶段研究的剂量扩展队列中的患者将被随机分为1：1，每三周静脉注射一次4.3或5.2毫克/公斤的STRO-002。患者不会被预先选择进行FolRα的表达，需要新鲜或存档的肿瘤组织样本进行FolRα表达的免疫组织化学分析。
Additional information on the study can be found at: https://clinicaltrials.gov/ct2/show/NCT03748186
有关这项研究的更多信息，请访问：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.
关于Stro-002治疗卵巢癌的一期试验STRO-002-GM1，一期开放标签、多中心、剂量递增试验，剂量扩展为STRO-002，已经完成登记。后续研究正在进行中，并将继续评估Stro-002在患有晚期上皮性卵巢癌(包括输卵管癌和原发性腹膜癌)的成人患者中的安全性、耐受性和初步抗肿瘤活性。该试验注册了Clinicaltrials.gov标识符NCT03748186。Sutro利用其专有的XpressCF®无细胞蛋白质合成和XpressCF+™位点特定结合技术发现、开发和制造STRO-002。
译文内容由第三方软件翻译。