JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

Last updated: January 7, 2026
Sponsor: Jacobio Pharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Solid Tumors

Small Cell Lung Cancer

Treatment

JAB-2485 (Aurora A inhibitor)

Clinical Study ID

NCT05490472
JAB-2485-1001
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 advancedsolid tumor

  • Dose Expansion phase cohorts must meet specific expression or gene mutationwhere indicated

  • Must be refractory to or become intolerant of existing therapy(ies) known to provideclinical 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

Exclusion Criteria:

  • Has central nervous system (CNS) metastases or carcinomatous meningitis, except ifCNS metastases treated and no evidence of radiographic progression or hemorrhage forat 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) ormultigated 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

Total Participants: 102
Treatment Group(s): 1
Primary Treatment: JAB-2485 (Aurora A inhibitor)
Phase: 1/2
Study Start date:
December 20, 2022
Estimated Completion Date:
August 31, 2027

Study Description

The primary objective of this study is to evaluate the safety and tolerability of JAB-2485 monotherapy to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) during Dose Escalation phase when administered in participants with advanced solid tumors; then to further evaluate preliminary antitumor activity of JAB-2485 monotherapy at the RP2D during Dose Expansion phase in patients with advanced solid tumors such as ER+ breast cancer, triple negative breast cancer (TNBC), AT-rich interaction domain 1A (ARID1A) mutant solid tumors and small cell lung cancer (SCLC).

Connect with a study center

  • Research site02

    Beijing, Beijing 100101
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing 1816670, Beijing Municipality 2038349 100101
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing 1816670, Beijing Municipality 2038349 100101
    China

    Active - Recruiting

  • Research site01

    Changchun, Jilin 130000
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun 2038180, Jilin 2036500 130000
    China

    Active - Recruiting

  • Research site03

    Jinan, Shandong 250117
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan 1805753, Shandong 1796328 250117
    China

    Active - Recruiting

  • Henry Ford Health System

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • Washington University

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • Mary Crowley Cancer Research

    Dallas 4684888, Texas 4736286 75230
    United States

    Active - Recruiting

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • University of Utah Huntsman Cancer Institute

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Active - Recruiting

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