RecruitingPhase 1Phase 2NCT05490472
JAB-2485 Activity 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
Sponsor
Jacobio Pharmaceuticals Co., Ltd.
Enrollment
102 participants
Start Date
Dec 20, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria8
- 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
Interventions
DRUGJAB-2485 (Aurora A inhibitor)
Administered orally
DRUGJAB-2485 (Aurora A inhibitor)
Administered orally
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05490472
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