[Translation] Phase Ib/II clinical study on the safety, pharmacokinetic characteristics and preliminary efficacy of SC0191 tablets combined with chemotherapy in patients with advanced ovarian cancer
Ib 期:主要目的:评估 SC0191 联合吉西他滨或紫杉醇在晚期卵巢癌患者中的安全性和耐受性,以确定 SC0191 联合吉西他滨或紫杉醇的治疗中 SC0191 的 II 期临床推荐剂量(RP2D)。次要目的:1.评估SC0191联合吉西他滨或紫杉醇在晚期卵巢癌患者中SC0191的药代动力学(PK)特征;2.评估 SC0191 联合吉西他滨或紫杉醇在晚期卵巢癌患者中的初步抗肿瘤活性。探索性目的:1. 探索预测性生物标记物与联合治疗抗肿瘤活性的相关性;2.探索药效学生物标志物的变化与 SC0191 暴露的相关性。
II 期:主要目的:评估 SC0191 联合吉西他滨或紫杉醇在晚期铂耐药或铂难治复发性高级别浆液性卵巢癌患者中的安全性和耐受性。次要目的:1.评估 SC0191 联合吉西他滨或紫杉醇在晚期铂耐药或铂难治复发性高级别浆液性卵巢癌患者中的抗肿瘤活性;2. 评估SC0191联合吉西他滨或紫杉醇在晚期卵巢癌患者中SC0191的药代动力学(PK)特征。探索性目的:1.探索预测性生物标记物与联合治疗抗肿瘤活性的相关性;2.探索药效学生物标志物的变化与 SC0191 暴露的相关性。
[Translation] Phase Ib: Primary objective: To evaluate the safety and tolerability of SC0191 combined with gemcitabine or paclitaxel in patients with advanced ovarian cancer, to determine the Phase II clinical recommended dose (RP2D) of SC0191 in the treatment of SC0191 combined with gemcitabine or paclitaxel. Secondary objectives: 1. To evaluate the pharmacokinetic (PK) characteristics of SC0191 combined with gemcitabine or paclitaxel in patients with advanced ovarian cancer; 2. To evaluate the preliminary anti-tumor activity of SC0191 combined with gemcitabine or paclitaxel in patients with advanced ovarian cancer. Exploratory objectives: 1. To explore the correlation between predictive biomarkers and the anti-tumor activity of combined treatment; 2. To explore the correlation between changes in pharmacodynamic biomarkers and SC0191 exposure.
Phase II: Primary objective: To evaluate the safety and tolerability of SC0191 combined with gemcitabine or paclitaxel in patients with advanced platinum-resistant or platinum-refractory recurrent high-grade serous ovarian cancer. Secondary objectives: 1. To evaluate the anti-tumor activity of SC0191 combined with gemcitabine or paclitaxel in patients with advanced platinum-resistant or platinum-refractory recurrent high-grade serous ovarian cancer; 2. To evaluate the pharmacokinetic (PK) characteristics of SC0191 combined with gemcitabine or paclitaxel in patients with advanced ovarian cancer. Exploratory objectives: 1. To explore the correlation between predictive biomarkers and the anti-tumor activity of combination therapy; 2. To explore the correlation between changes in pharmacodynamic biomarkers and SC0191 exposure.