JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

NCT05490472 · tracked via the Priya Life Science USA tracker

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Phase

Phase 1/2

Started

2022-12-20

Last updated

2026-01-09

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

Study summary

This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

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