MC# 22-39 - A Phase I/IIa, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients with Advanced Solid Tumors

  • Agent(s): JAB-2485
  • Disease Type(s): Solid Tumor, Lung-SCLC, Breast- Triple Negative, Breast - ER+
  • Phase(s): I, II
  • Drug Classification(s): Small Molecule, Targeted Therapy
  • Molecular Target(s): Aurora-A

Mechanism of Action

JAB-2485 is a small molecule Aurora A inhibitor. Inhibition of Aurora A activity at the cellular level, induces apoptosis and inhibits tumor growth.


In this study, the sponsor and investigators want to learn:

  • How much of JAB-2485 can be given with an acceptable level of side effects
  • The effects of JAB-2485 (good and bad) 
  • How much of JAB-2485 is absorbed into the blood and how fast it is removed
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
  • Experiencing unresolved CTCAE 5.0 Grade >1 toxicities
  • Clinically significant eye disorders


  • Dallas, TX - Mary Crowley Cancer Research - Medical City
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Re: MC# 22-39