[Translation] A Phase I/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of ST-1703 tablets in patients with HER2-positive advanced solid tumors
Ⅰ期 剂量递增阶段
主要目的:
评价ST-1703片治疗经标准治疗失败的HER2阳性晚期恶性实体瘤患者的安全性和耐受性,并探索ST-1703片的最大耐受剂量(MTD)。
次要目的:
1) 评价ST-1703片的药代动力学(PK)特征;
2) 初步评价ST-1703片的抗肿瘤疗效。
Ⅱa期
主要目的:
评价ST-1703片在HER2阳性的晚期乳腺癌(包括乳腺癌脑转移)和其他HER2阳性晚期恶性实体瘤(如胃癌、结直肠癌、胆道癌、肺癌、食管癌、卵巢癌、唾液腺癌、膀胱癌和脑胶质细胞癌等)患者中的疗效。
次要目的:
1) 进一步评价ST-1703片的药代动力学(PK)特征;
2) 进一步评价ST-1703片的安全性和耐受性。
[Translation] Phase I Dose escalation phase
Main purpose:
To evaluate the safety and tolerability of ST-1703 tablets in patients with HER2-positive advanced malignant solid tumors who have failed standard treatment, and to explore the maximum tolerated dose (MTD) of ST-1703 tablets.
Secondary purpose:
1) To evaluate the pharmacokinetic (PK) characteristics of ST-1703 tablets;
2) To preliminarily evaluate the anti-tumor efficacy of ST-1703 tablets.
Phase IIa
Main purpose:
To evaluate the efficacy of ST-1703 tablets in patients with HER2-positive advanced breast cancer (including brain metastases from breast cancer) and other HER2-positive advanced malignant solid tumors (such as gastric cancer, colorectal cancer, biliary tract cancer, lung cancer, esophageal cancer, ovarian cancer, salivary gland cancer, bladder cancer, and brain glial cell cancer, etc.).
Secondary purpose:
1) To further evaluate the pharmacokinetic (PK) characteristics of ST-1703 tablets;
2) To further evaluate the safety and tolerability of ST-1703 tablets.