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在激素受体阳性、人表皮生长因子受体2阴性的晚期/转移性乳腺癌及其他晚期恶性实体瘤的中国受试者中评价RGT-419B单药治疗的安全性与耐受性的I期研究
[Translation] Phase I to evaluate the safety and tolerability of RGT-419B monotherapy in Chinese subjects with hormone receptor positive, human epidermal growth factor receptor 2 negative advanced/metastatic breast cancer and other advanced malignant solid tumors Research
评价RGT-419B在激素受体阳性/人表皮生长因子受体2阴性晚期/转移性乳腺癌(HR+/HER2-ABC)及其他晚期恶性实体瘤患者中的安全性和耐受性,考察药代动力学特征,初步评估抗肿瘤疗效。
[Translation] To evaluate the safety and tolerability of RGT-419B in patients with hormone receptor positive/human epidermal growth factor receptor 2 negative advanced/metastatic breast cancer (HR+/HER2-ABC) and other advanced malignant solid tumors, and to investigate pharmacokinetics Kinetic characteristics, preliminary evaluation of anti-tumor efficacy.
一项评价RGT-264磷酸盐片在晚期实体瘤受试者中的安全性、耐受性、药代动力学及初步疗效的I期临床研究
[Translation] A phase I clinical study evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of RGT-264 phosphate tablets in subjects with advanced solid tumors
主要目的:确定RGT-264单药的最大耐受剂量(MTD)或最大给药剂量(MAD)、II期研究推荐剂量(RP2D);评价RGT-264单药在晚期实体瘤受试者中的安全性及耐受性。次要目的:评价RGT-264在晚期实体瘤受试者中的药代动力学(PK)特征;初步评价RGT-264的抗肿瘤疗效。
[Translation] Main purpose: To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of RGT-264 single drug, the recommended dose of phase II study (RP2D); to evaluate the effect of RGT-264 single drug in subjects with advanced solid tumors Safety and Tolerability. Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of RGT-264 in subjects with advanced solid tumors; to preliminarily evaluate the antitumor efficacy of RGT-264.
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of RGT-264 Phosphate Tablets in Subjects With Advanced Solid Tumors
This is a Phase 1 dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of RGT-264 as monotherapy in subjects with advanced solid tumors.
100 Clinical Results associated with Shanghai Qilu Ruige Pharmaceutical R&D Co., Ltd.
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100 Translational Medicine associated with Shanghai Qilu Ruige Pharmaceutical R&D Co., Ltd.