[Translation] A phase I/II clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of KBD102430 in patients with advanced solid tumors.
I期主要目的:评价KBD102430在晚期实体瘤试验参与者中的安全性和耐受性;评价KBD102430在晚期实体瘤试验参与者中的剂量限制性毒性(DLT),确定最大耐受剂量(MTD)和/或Ⅱ期推荐剂量(RP2D)。
II期主要目的:评价KBD102430在HRR基因突变晚期实体瘤如卵巢癌、乳腺癌、前列腺癌等试验参与者中的有效性。
探索性目的(适用与I/II期)探索生物标志物与疗效之间的相关性;探索群体药代动力学(PopPK)分析;探索暴露量与疗效和不良事件(AE)之间的关系。
[Translation] Phase I primary objectives: To evaluate the safety and tolerability of KBD102430 in participants of trials with advanced solid tumors; to evaluate dose-limiting toxicities (DLT) of KBD102430 in participants of trials with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and/or the recommended dose for Phase II (RP2D).
Phase II primary objectives: To evaluate the efficacy of KBD102430 in participants of trials with HRR-mutant advanced solid tumors such as ovarian cancer, breast cancer, and prostate cancer.
Exploratory objectives (applicable to Phase I/II): To explore the correlation between biomarkers and efficacy; to explore population pharmacokinetic (PopPK) analysis; to explore the relationship between exposure and efficacy and adverse events (AEs).