[Translation] A multicenter, open-label, first-in-human Phase I clinical study evaluating the safety, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced/metastatic breast cancer or locally advanced/metastatic solid tumors
确定推荐剂量范围和/或最大耐受剂量,并评估INV-6452口服给药在晚期/转移性HR+/HER2-乳腺癌或局部晚期/转移性实体瘤成年患者中的剂量限制性毒性;评估INV-6452在晚期/转移性HR+/HER2-乳腺癌或局部晚期/转移性实体瘤成年患者中的安全性、耐受性、PK/PD特征和初步抗肿瘤活性。
[Translation] To determine the recommended dose range and/or maximum tolerated dose and evaluate the dose-limiting toxicities of oral INV-6452 in adult patients with advanced/metastatic HR+/HER2- breast cancer or locally advanced/metastatic solid tumors; to evaluate the safety, tolerability, PK/PD characteristics and preliminary antitumor activity of INV-6452 in adult patients with advanced/metastatic HR+/HER2- breast cancer or locally advanced/metastatic solid tumors.