JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
NCT ID: NCT05490472
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
102 participants
INTERVENTIONAL
2022-12-20
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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JAB-2485 monotherapy, Phase 1, Dose Escalation
Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D.
JAB-2485 (Aurora A inhibitor)
Administered orally
JAB-2485 monotherapy, Phase 2a, Dose Expansion
JAB-2485 will be administered as monotherapy in patients with specific tumor types to evaluate the preliminary antitumor activity.
JAB-2485 (Aurora A inhibitor)
Administered orally
Interventions
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JAB-2485 (Aurora A inhibitor)
Administered orally
JAB-2485 (Aurora A inhibitor)
Administered orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Jacobio Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Henry Ford Health System
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Mary Crowley Cancer Research
Dallas, Texas, 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
Jilin Cancer Hospital
Changchun, Jilin, China
Shandong Cancer Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Other Identifiers
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JAB-2485-1001
Identifier Type: -
Identifier Source: org_study_id