Recruiting
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
ClinicalTrials.gov IDNCT05490472
PhasePHASE1, PHASE2
Enrollment102
SponsorJacobio Pharmaceuticals Co., Ltd.
Age18 Years and older
SexALL
Conditions studied
Solid Tumors, ER+ Breast Cancer, Triple Negative Breast Cancer, TNBC, ARID1A Gene Mutation, Small Cell Lung Cancer, SCLC
About this study
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
Interventions
- Drug: JAB-2485 (Aurora A inhibitor) — Administered orally
- Drug: JAB-2485 (Aurora A inhibitor) — Administered orally
Primary outcomes
- Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs) (First 21 days of Cycle 1)
- Dose Escalation phase: Number of participants with adverse events (AEs) (Up to 3 years)
- Dose Expansion phase: Objective Response Rate (ORR) (Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD))
- Dose Expansion phase: Duration of Response (DOR) (Up to 3 years)
Eligibility information
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
Study locations
- Henry Ford Health System, Detroit, Michigan 48202 United States
- Washington University, St Louis, Missouri 63110 United States
- Mary Crowley Cancer Research, Dallas, Texas 75230 United States
- University of Utah Huntsman Cancer Institute, Salt Lake City, Utah 84112 United States
- Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing Municipality 100101 China
- Peking University Third Hospital, Beijing, Beijing Municipality 100101 China
- Jilin Cancer Hospital, Changchun, Jilin 130000 China
- Shandong Cancer Hospital, Jinan, Shandong 250117 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-20.