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JAB-2485 for Advanced Solid Tumors

This study is testing a new oral drug called JAB-2485 for adults with advanced solid tumors, including ER+ breast cancer, triple negative breast cancer (TNBC), ARID1A gene mutated tumors, and small cell lung cancer (SCLC). The main goals are to see how safe JAB-2485 is, what side effects it might cause, and to find the best dose. Researchers will also look at whether JAB-2485 can shrink tumors. You might be able to join if you have a solid tumor that has spread or is locally advanced, and if previous treatments haven't worked or you couldn't tolerate them. You will also need to provide a tumor sample for testing. The study plans to enroll 102 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive the study drug. It is designed to first find the safest dose and then to evaluate how well the drug works in about 102 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to 3 years. Tumor response will also be measured for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05490472

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Jacobio Pharmaceuticals Co., Ltd.
~102 participants
Updated 2026-01-09 on ClinicalTrials.gov
What's tested:JAB-2485 (Aurora A inhibitor)

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
Measured over First 21 days of Cycle 1
+3 more outcomes measured

Conditions

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

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Where it's being run

8 sites across 7 states
Beijing Municipality2
Michigan1
Missouri1
Texas1
Utah1
Jilin1
Shandong1

Who to contact

Jacobio Pharmaceuticals
[email protected]
(781) 918-6670
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.