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Center","06351",{"type":53,"coordinates":406},[393,394],{"lat":394,"lon":393},{"facility":409,"status":46,"city":410,"state":29,"zip":411,"country":412,"countryCode":413,"cosmosGeoPoint":414,"geoPoint":418,"contacts":29},"Taichung Veterans General Hospital","Taichung","407219","Taiwan","TW",{"type":53,"coordinates":415},[416,417],120.6839,24.1469,{"lat":417,"lon":416},{"facility":420,"status":46,"city":421,"state":29,"zip":29,"country":412,"countryCode":413,"cosmosGeoPoint":422,"geoPoint":426,"contacts":29},"National Taiwan University Cancer Center","Taipei",{"type":53,"coordinates":423},[424,425],121.52639,25.05306,{"lat":425,"lon":424},{"facility":428,"status":46,"city":421,"state":29,"zip":29,"country":412,"countryCode":413,"cosmosGeoPoint":429,"geoPoint":431,"contacts":29},"National Taiwan University Hospital",{"type":53,"coordinates":430},[424,425],{"lat":425,"lon":424},{"type":433,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100570348","phase-1-a-study-of-bh-30643-in-subjects-with-locally-advanced-or-metastatic-nsclc-harboring-egfr-andor-her2-mutations-100570348",false,"NCT06706076","A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and\u002For HER2 Mutations","A Phase 1\u002F2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Adult Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and\u002For HER2 Mutations (SOLARA)","SOLARA","Inclusion Criteria:\n\n* ≥ 18 years or legal adult.\n* 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.\n* Has at least 1 measurable target extracranial lesion according to RECIST v1.1.\n* Eastern Cooperative Oncology Group Performance Status ≤ 1.\n* Has a life expectancy of ≥ 3 months.\n* Has adequate hematologic, hepatic, and renal function.\n\n  * The above are a summary; other Inclusion Criteria details may apply.\n\nExclusion Criteria:\n\n* History of any concurrent malignancy within the previous 2 years.\n* Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).\n* Unresolved toxicities from prior therapies.\n* Any significant and uncontrolled medical condition, such as infection.\n* Active or history of interstitial lung disease from any cause\n* Clinically significant cardiovascular event within 6 months or significant history of major organ.\n\n  * The above are a summary; other Exclusion Criteria details may apply.","ALL","18 Years",{"count":445,"type":446},675,"ESTIMATED","INTERVENTIONAL",[449,450],"PHASE1","PHASE2","This Phase1\u002F2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and\u002For HER2 mutations.\n\nPhase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643, both as a monotherapy and in combination with chemotherapy.\n\nPhase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR\u002FHER2 mutation subtypes and\u002For treatment history at the RP2D, as well as the population PK.",[453],"NSCLC (Advanced Non-small Cell Lung Cancer)",[455,456,457,458,459,460,461,462,463,464,465,26,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484,485,486,487,488,489,490,491,492,493,494],"NSCLC","Locally Advanced NSCLC","Metastatic 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