A Phase 1/2a, 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
A Phase 1/2a, 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
NCT #
NCT05490472
Condition(s)
Solid Tumors
Molecular Target(s)
None
Drug Classification(s)
JAB-2485 is a small molecule Aurora A inhibitor
Agents(s)
JAB-2485
Phase(s)
I/II
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.
Purpose
- How much of the study drug can be given with an acceptable level of side effects• The effects of the study drug (good and bad)
- The effects of the study drug on tumor growth
- How much of the study drug is absorbed into the blood and how fast it is removed
- How the study drug is acting in your body
- 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
- 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
None
Location
MCD
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