Clinical Trials in the USA / NCT05490472
Recruiting
Phase 1/2
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
NCT05490472 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Solid TumorsER+ Breast CancerTriple Negative Breast Cancer, TNBCARID1A Gene MutationSmall Cell Lung Cancer, SCLC
Investigational drug(s) / intervention(s)
JAB-2485 (Aurora A inhibitor)JAB-2485 (Aurora A inhibitor)
JAB-2485 (Aurora A inhibitor): Administered orally
JAB-2485 (Aurora A inhibitor): Administered orally
Study summary
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
Eligibility
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
Primary outcome measure(s)
- Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs) — First 21 days of Cycle 1
A DLT is defined as an adverse event (AE) regardless of attribution unless clearly related to underlying disease or extraneous cause during the first 21 days of Cycle 1 (DLT observation period). - Dose Escalation phase: Number of participants with adverse events (AEs) — Up to 3 years
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0 - Dose Expansion phase: Objective Response Rate (ORR) — Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)
ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1 - Dose Expansion phase: Duration of Response (DOR) — Up to 3 years
DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| Mary Crowley Cancer Research | Dallas | Texas | Recruiting |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | Recruiting |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | Recruiting |
| Peking University Third Hospital | Beijing | Beijing Municipality | Recruiting |
| Jilin Cancer Hospital | Changchun | Jilin | Recruiting |
| Shandong Cancer Hospital | Jinan | Shandong | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05490472 on ClinicalTrials.gov ↗ ← All trials in the USA