Recruiting
Phase 1
Phase 2

JAB-2485

Sponsor:

Jacobio Pharmaceuticals Co., Ltd.

Code:

NCT05490472

Conditions

Solid Tumors

ER+ Breast Cancer

Triple Negative Breast Cancer, TNBC

ARID1A Gene Mutation

Small Cell Lung Cancer, SCLC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JAB-2485 (Aurora A inhibitor)

JAB-2485 (Aurora A inhibitor)

Study Details

Brief summary:

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

Conditions

Solid Tumors

ER+ Breast Cancer

Triple Negative Breast Cancer, TNBC

ARID1A Gene Mutation

Small Cell Lung Cancer, SCLC

Study ID

NCT05490472

Start date

Dec 20, 2022

Status verified date

Nov, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

102 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JAB-2485 monotherapy, Phase 1, Dose Escalation

Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D.

experimental: 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.

Interventions

JAB-2485 (Aurora A inhibitor)

Administered orally

JAB-2485 (Aurora A inhibitor)

Administered orally

Primary outcome measure

  • Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs) [ Time Frame: First 21 days of Cycle 1 ]
  • Dose Escalation phase: Number of participants with adverse events (AEs) [ Time Frame: Up to 3 years ]
  • Dose Expansion phase: Objective Response Rate (ORR) [ Time Frame: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD) ]
  • Dose Expansion phase: Duration of Response (DOR) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Jacobio Pharmaceuticals

(781) 918-6670clinicaltrials@jacobiopharma.com

Locations

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75230

University of Utah Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

More Information

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Last update posted

Jan 9, 2026

Last verified

Nov, 2025

Keywords

  • Aurora A inhibitor
  • ARID1A Gene Mutation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jacobio Pharmaceuticals Co., Ltd. on 2026-01-09.