JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Solid Tumors, ER+ Breast Cancer, Triple Negative Breast Cancer, TNBC, ARID1A Gene Mutation, Small Cell Lung Cancer, SCLC
In brief
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
Key facts
- Study ID
- NCT05490472
- Run by
- Jacobio Pharmaceuticals Co., Ltd.
- People needed
- 102
- Starts
- 2022-12-20
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Henry Ford Health System — Detroit, Michigan, United States (enrolling)
- Washington University — St Louis, Missouri, United States (enrolling)
- Mary Crowley Cancer Research — Dallas, Texas, United States (enrolling)
- University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
- Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)
- Jilin Cancer Hospital — Changchun, Jilin, China (enrolling)
- Shandong Cancer Hospital — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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