这项1/2期、开放标签、多中心研究将评估BH-30643在有EGFR和/或HER2突变的NSCLC患者中的安全性、耐受性、药物动力学(PK)、药效学和初步抗肿瘤活性。 第1阶段将确定BH-30643的推荐第2阶段剂量（ RP2D ）和（如适用）最大耐受剂量（ MTD ） ，无论是作为单一治疗还是与化疗联合使用。 第2阶段将进一步评估抗肿瘤
适应症：NSCLC (Advanced Non-small Cell Lung Cancer)
入组条件
纳入标准
- ≥ 18 years or legal adult.
- Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21.
- Has at least 1 measurable target extracranial lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group Performance Status ≤ 1.
- Has a life expectancy of ≥ 3 months.
- Has adequate hematologic, hepatic, and renal function.
排除标准
- History of any concurrent malignancy within the previous 2 years.
- Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).
- Unresolved toxicities from prior therapies.
- Any significant and uncontrolled medical condition, such as infection.
- Active or history of interstitial lung disease from any cause
- Clinically significant cardiovascular event within 6 months or significant history of major organ.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。