[Translation] A phase I clinical trial to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of BEBT-260 alone or in combination with gemcitabine in patients with advanced solid tumors with p53 overexpression
Ia期剂量递增阶段主要目的:评价BEBT-260在p53过表达的晚期实体瘤患者中的耐受性和安全性;探索BEBT-260在p53过表达的晚期实体瘤患者中的药代动力学特征。次要目的:探索BEBT-260在p53过表达的晚期实体瘤患者的初步疗效;探索药效学及安全性相关的生物标记物。
Ib期剂量扩展阶段主要目的:评价BEBT-260单药剂量扩展或联合低剂量吉西他滨(LDG)治疗p53过表达的晚期实体瘤患者的安全性、耐受性;为BEBT-260单药剂量扩展或联合LDG治疗p53过表达的晚期实体瘤患者的II期临床试验推荐剂量(RP2D)。次要目的:探索BEBT-260单药剂量扩展或联合LDG治疗p53过表达的晚期实体瘤患者的药代动力学特征;评价BEBT-260单药剂量扩展或联合LDG治疗p53过表达的晚期实体瘤患者的初步疗效;探索与BEBT-260单药剂量扩展或联合LDG给药药效学及安全性相关的生物标记物。
[Translation] The main purpose of the Phase Ia dose escalation phase is to evaluate the tolerability and safety of BEBT-260 in patients with advanced solid tumors with p53 overexpression; to explore the pharmacokinetic characteristics of BEBT-260 in patients with advanced solid tumors with p53 overexpression. Secondary objectives: to explore the preliminary efficacy of BEBT-260 in patients with advanced solid tumors with p53 overexpression; to explore biomarkers related to pharmacodynamics and safety.
The main purpose of the Phase Ib dose expansion phase is to evaluate the safety and tolerability of BEBT-260 monotherapy or combined with low-dose gemcitabine (LDG) in the treatment of patients with advanced solid tumors with p53 overexpression; to recommend the dose (RP2D) for the Phase II clinical trial of BEBT-260 monotherapy or combined with LDG in the treatment of patients with advanced solid tumors with p53 overexpression. Secondary objectives: To explore the pharmacokinetic characteristics of BEBT-260 as a single agent or in combination with LDG in the treatment of patients with advanced solid tumors with overexpression of p53; to evaluate the preliminary efficacy of BEBT-260 as a single agent or in combination with LDG in the treatment of patients with advanced solid tumors with overexpression of p53; to explore biomarkers related to the pharmacodynamics and safety of BEBT-260 as a single agent or in combination with LDG.