JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
Recruiting · NCT05490472 · Interventional (participants receive a specific treatment) · Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
JAB-2485 (Aurora A inhibitor)
What this trial is about
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
16 locations listed across 4 US states.
- Henry Ford Health System - Detroit, Michigan, United States
- Henry Ford Health System - Detroit, Michigan, United States
- Washington University - St Louis, Missouri, United States
- Washington University - St Louis, Missouri, United States
- Mary Crowley Cancer Research - Dallas, Texas, United States
- Mary Crowley Cancer Research - Dallas, Texas, United States
- University of Utah Huntsman Cancer Institute - Salt Lake City, Utah, United States
- University of Utah Huntsman Cancer Institute - Salt Lake City, Utah, United States
- Cancer Hospital Chinese Academy of Medical Sciences - Beijing, Beijing Municipality, China
- Peking University Third Hospital - Beijing, Beijing Municipality, China
- Cancer Hospital Chinese Academy of Medical Sciences - Beijing, Beijing Municipality, China
- Peking University Third Hospital - Beijing, Beijing Municipality, China
- Jilin Cancer Hospital - Changchun, Jilin, China
- Jilin Cancer Hospital - Changchun, Jilin, China
- Shandong Cancer Hospital - Jinan, Shandong, China
- Shandong Cancer Hospital - Jinan, Shandong, China