[Translation] A single-arm, open-label, multi-center phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and efficacy of KM501 double-antibody ADC in subjects with advanced solid tumors with HER2 expression, amplification or mutation
Ia期:
主要目的:
评价KM501在HER2表达、扩增或突变的晚期实体瘤受试者中的安全性和耐受性。
确定KM501的最大耐受剂量(MTD)(如有),以及II期临床推荐剂量(RP2D)。
次要目的:
评价KM501在HER2表达、扩增或突变的晚期实体瘤受试者中的药代动力学特征。
评价KM501在HER2表达、扩增或突变的晚期实体瘤受试者中的有效性。
评价KM501在HER2表达、扩增或突变的晚期实体瘤受试者中的免疫原性。
Ib期:
主要目的:
评价KM501单药治疗在HER2表达、扩增或突变的特定类型肿瘤受试者中的有效性。
次要目的:
评价KM501单药治疗在HER2表达、扩增或突变的特定类型肿瘤受试者中的安全性和耐受性。
评价KM501单药治疗在HER2表达、扩增或突变的特定类型肿瘤受试者中的药代动力学特征。
评价KM501单药治疗在HER2表达、扩增或突变的特定类型肿瘤受试者中的免疫原性。
探索性目的:
探索HER2表达、扩增或突变与KM501抗肿瘤疗效之间的关系。
[Translation] Phase Ia:
main purpose:
To evaluate the safety and tolerability of KM501 in subjects with advanced solid tumors expressing, amplified or mutated in HER2.
Determine the maximum tolerated dose (MTD) of KM501 (if any), and the recommended dose (RP2D) for phase II clinical trials.
Secondary purpose:
To evaluate the pharmacokinetic characteristics of KM501 in subjects with advanced solid tumors expressing, amplified or mutated in HER2.
To evaluate the effectiveness of KM501 in subjects with advanced solid tumors that express, amplify, or mutate HER2.
To evaluate the immunogenicity of KM501 in subjects with advanced solid tumors expressing, amplified or mutated in HER2.
Phase Ib:
main purpose:
To evaluate the effectiveness of KM501 monotherapy in subjects with specific types of tumors that express, amplify or mutate HER2.
Secondary purpose:
To evaluate the safety and tolerability of KM501 monotherapy in subjects with specific types of tumors that express, amplify or mutate HER2.
To evaluate the pharmacokinetic characteristics of KM501 monotherapy in subjects with specific types of tumors expressing, amplifying or mutating HER2.
To evaluate the immunogenicity of KM501 monotherapy in subjects with specific types of tumors that express, amplify, or mutate HER2.
Exploratory purpose:
To explore the relationship between HER2 expression, amplification or mutation and the antitumor efficacy of KM501.