JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

NCT ID: NCT05490472

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2027-08-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Solid Tumors ER+ Breast Cancer Triple Negative Breast Cancer, TNBC ARID1A Gene Mutation Small Cell Lung Cancer, SCLC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JAB-2485 monotherapy, Phase 1, Dose Escalation

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

Group Type EXPERIMENTAL

JAB-2485 (Aurora A inhibitor)

Intervention Type DRUG

Administered orally

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.

Group Type EXPERIMENTAL

JAB-2485 (Aurora A inhibitor)

Intervention Type DRUG

Administered orally

Interventions

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JAB-2485 (Aurora A inhibitor)

Administered orally

Intervention Type DRUG

JAB-2485 (Aurora A inhibitor)

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jacobio Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Henry Ford Health System

Detroit, Michigan, United States

Site Status RECRUITING

Washington University

St Louis, Missouri, United States

Site Status RECRUITING

Mary Crowley Cancer Research

Dallas, Texas, United States

Site Status RECRUITING

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, China

Site Status RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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United States China

Central Contacts

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Jacobio Pharmaceuticals

Role: CONTACT

Phone: (781) 918-6670

Email: [email protected]

Other Identifiers

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JAB-2485-1001

Identifier Type: -

Identifier Source: org_study_id