[Translation] A Phase Ia/Ib clinical study evaluating the safety, tolerability, pharmacokinetics and efficacy of the CDK2/4/6 inhibitor TYK-00540 tablets in patients with advanced solid tumors
主要目的:单药递增阶段:评价不同剂量TYK-00540在局部晚期/转移性实体瘤患者中的安全性和耐受性;评估DLT,并确定TYK-00540的最大耐受剂量(MTD)。单药扩展阶段:评估TYK-00540单药在铂耐药HGSOC或局部晚期/转移性TNBC患者中的疗效。次要目的:考察TYK-00540在局部晚期/转移性实体瘤患者中单次、多次口服给药后的药代动力学特征;评估TYK-00540在局部晚期/转移性实体瘤患者中的初步抗肿瘤活性。单药扩展阶段:评价TYK-00540单药在铂耐药HGSOC或局部晚期/转移性TNBC患者中的安全性及其他疗效指标;进一步评估TYK-00540单药条件下在人体中的药代动力学特征,及初步考察食物对TYK-00540药动学的影响。
[Translation] Primary objectives: Single-agent escalation phase: Evaluate the safety and tolerability of different doses of TYK-00540 in patients with locally advanced/metastatic solid tumors; evaluate DLT, and determine the maximum tolerated dose (MTD) of TYK-00540. Single-agent expansion phase: Evaluate the efficacy of TYK-00540 monotherapy in patients with platinum-resistant HGSOC or locally advanced/metastatic TNBC. Secondary objectives: Investigate the pharmacokinetic characteristics of TYK-00540 after single and multiple oral administration in patients with locally advanced/metastatic solid tumors; Evaluate the preliminary anti-tumor activity of TYK-00540 in patients with locally advanced/metastatic solid tumors. Single-agent expansion phase: Evaluate the safety and other efficacy indicators of TYK-00540 monotherapy in patients with platinum-resistant HGSOC or locally advanced/metastatic TNBC; further evaluate the pharmacokinetic characteristics of TYK-00540 monotherapy in humans, and preliminarily investigate the effect of food on the pharmacokinetics of TYK-00540.