這項1/2期、開放標籤、多中心研究將評估BH-30643在有EGFR和/或HER2突變的NSCLC患者中的安全性、耐受性、藥物動力學(PK)、藥效學和初步抗腫瘤活性。 第1階段將確定BH-30643的推薦第2階段劑量（ RP2D ）和（如適用）最大耐受劑量（ MTD ） ，無論是作為單一治療還是與化療聯合使用。 第2階段將進一步評估抗腫瘤
適應症：NSCLC (Advanced Non-small Cell Lung Cancer)
收案條件
納入條件
- ≥ 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.
排除條件
- 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.
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。