Beijing Xuanzhu Combio Co., Ltd.

Phase Ia: Primary objectives: To evaluate the safety and tolerability of KM501 in subjects with advanced solid tumors expressing, amplified or mutated HER2. To determine the maximum tolerated dose (MTD) of KM501 (if any), and the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: To evaluate the pharmacokinetic characteristics of KM501 in subjects with advanced solid tumors expressing, amplified or mutated HER2. To evaluate the efficacy of KM501 in subjects with advanced solid tumors expressing, amplified or mutated HER2. To evaluate the immunogenicity of KM501 in subjects with advanced solid tumors expressing, amplified or mutated HER2. Phase Ib: Primary objectives: To evaluate the efficacy of KM501 monotherapy in subjects with specific types of tumors expressing, amplified or mutated HER2. Secondary objectives: To evaluate the safety and tolerability of KM501 monotherapy in subjects with specific types of tumors expressing, amplified or mutated HER2. To evaluate the pharmacokinetic characteristics of KM501 monotherapy in subjects with specific types of tumors expressing, amplified or mutated HER2. To evaluate the immunogenicity of KM501 monotherapy in subjects with specific tumor types that express, amplify or mutate HER2. Exploratory purpose: To explore the relationship between HER2 expression, amplification or mutation and the anti-tumor efficacy of KM501.

Primary purpose: To evaluate the safety and tolerability of KM602 in patients with advanced solid tumors, determine the maximum tolerated dose (MTD) of KM602 (if any) and the recommended dose (RP2D) for Phase II clinical trials; Secondary purpose: To preliminarily evaluate the anti-tumor activity of KM602 in patients with advanced solid tumors, study the pharmacokinetic characteristics of KM602 in patients with advanced solid tumors, and the immunogenicity of KM602; Exploratory purpose: To explore the pharmacodynamics and predictive biomarkers related to KM602 treatment.

Phase Ia Main objectives: 1. Evaluate the safety and tolerability of KM257 in patients with HER2-positive or expressed advanced solid tumors. 2. Determine the maximum tolerated dose (MTD) of KM257 (if any), and the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: 1. Determine the pharmacokinetic characteristics of KM257 in patients with HER2-positive or expressed advanced solid tumors. 2. Evaluate the efficacy of KM257 in patients with HER2-positive or expressed advanced solid tumors. 3. Evaluate the immunogenicity of KM257 in patients with HER2-positive or expressed advanced solid tumors. Exploratory objectives: 1. Explore the blood concentration levels of cytokines in patients with HER2-positive or expressed advanced solid tumors. Phase Ib Main objectives: 1. Evaluate the efficacy of KM257 alone or in combination therapy in subjects with specific types of tumors that express or amplify HER2. Secondary objectives: 1. Evaluate the safety and tolerability of KM257 alone or in combination therapy in subjects with specific types of tumors that express or amplify HER2. 2. Evaluate the pharmacokinetic characteristics of KM257 monotherapy or combination therapy in subjects with specific tumor types that express or amplify HER2. 3. Evaluate the immunogenicity of KM257 monotherapy or combination therapy in subjects with specific tumor types that express or amplify HER2.