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.
Purpose
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
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
