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JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
Trial Status: active
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult
participants with advanced solid tumors.
Inclusion Criteria
Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must be able to provide an archived tumor sample
Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor
Dose Expansion phase cohorts must meet specific expression or gene mutation where indicated
Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition
Must have at least 1 measurable lesion per RECIST v1.1
Must have adequate organ functions
Must be able to swallow and retain orally administered medication
Exclusion Criteria
Has central nervous system (CNS) metastases or carcinomatous meningitis, except if CNS metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days
Active infection requiring systemic treatment within 7 days
Active hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
Any severe and/or uncontrolled medical conditions
left ventricular ejection fraction (LVEF) ≤50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA)
QT interval using Fridericia's formula (QTcF) interval >470 msec