Solid TumorsPhase 1/2NCT05490472
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
A Phase 1/2 study testing JAB-2485 (Aurora A inhibitor) in people with Solid Tumors and ER+ Breast Cancer, run by Jacobio Pharmaceuticals Co., Ltd. at 8 sites in 2 countries.
Trial summary
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, ER+ Breast Cancer, Triple Negative Breast Cancer, TNBC
- What is being tested?
- JAB-2485 (Aurora A inhibitor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 20 Dec 2022to Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
Mary Crowley Cancer Research
Dallas, Texas, 75230
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
- Recruiting
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
- Recruiting
Washington University
St Louis, Missouri, 63110
China4 sites, 4 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100101
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100101
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130000
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
About this study
Official title: A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
Read the detailed 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).
- Conditions
- Solid Tumors, ER+ Breast Cancer, Triple Negative Breast Cancer, TNBC, ARID1A Gene Mutation, Small Cell Lung Cancer, SCLC
- Being tested
- JAB-2485 (Aurora A inhibitor)
- Keywords
- Aurora A inhibitor, ARID1A Gene Mutation
- Medical subject headings
- Triple Negative Breast Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-2485 (Aurora A inhibitor)Drug
Administered orally
JAB-2485 (Aurora A inhibitor)Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| JAB-2485 monotherapy, Phase 1, Dose Escalation | Experimental | Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D. Receives: Drug: JAB-2485 (Aurora A inhibitor) |
| JAB-2485 monotherapy, Phase 2a, Dose Expansion | Experimental | JAB-2485 will be administered as monotherapy in patients with specific tumor types to evaluate the preliminary antitumor activity. Receives: Drug: JAB-2485 (Aurora A inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
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).
Measured: First 21 days of Cycle 1
Dose Escalation phase: Number of participants with adverse events (AEs)
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0
Measured: Up to 3 years
Dose Expansion phase: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1
Measured: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)
Dose Expansion phase: Duration of Response (DOR)
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.
Measured: Up to 3 years
Secondary outcomes (13)
Dose Escalation phase: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with PR or CR based on RECIST v1.1
Measured: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)
Dose Escalation and Dose Expansion phase: Time to response (TTR)
TTR is defined as the interval of time between the date of first treatment to the first documented response (CR or PR) as determined by investigator assessment per RECIST v1.1
Measured: Up to 3 years
Dose Escalation phase: Duration of Response (DOR)
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
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax)
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples, including peak plasma concentration (Cmax)
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: time to peak plasma concentration(Tmax)
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including time to peak plasma concentration (tmax)
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: Ctrough
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including pre-dose through concentration (Ctrough)
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: Area under the curve (AUC)
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including area under the plasma concentration versus time curve (AUC)
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: half-life (t½)
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including half-life (t½)
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: total body clearance
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including total body clearance
Measured: Up to 3 years
Dose Expansion phase: Progression Free Survival (PFS)
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per RECIST v1.1 or death which occurs first.
Measured: Up to 3 years
Dose Expansion Phase 2a: Overall Survival (OS)
OS is defined as the length of time between the date of first treatment to the date of death
Measured: Up to 3 years
Dose Expansion phase: Disease Control Rate (DCR)
DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1
Measured: Up to 3 years
Dose Expansion phase: Number of participants with adverse events (AEs)
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start20 Dec 2022
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490472
- Sponsor's protocol ID
- JAB-2485-1001
- Status last verified
- Nov 2025
- First submitted
- 25 Jul 2022
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05490472
- Acronym / sponsor ID
- JAB-2485-1001
- Conditions
- Solid Tumors, ER+ Breast Cancer, Triple Negative Breast Cancer, TNBC, ARID1A Gene Mutation, Small Cell Lung Cancer, SCLC
- Keywords
- Aurora A inhibitor, ARID1A Gene Mutation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JAB-2485 monotherapy, Phase 1, Dose Escalation | Experimental | Drug: JAB-2485 (Aurora A inhibitor)Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D. |
| JAB-2485 monotherapy, Phase 2a, Dose Expansion | Experimental | Drug: JAB-2485 (Aurora A inhibitor)JAB-2485 will be administered as monotherapy in patients with specific tumor types to evaluate the preliminary antitumor activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JAB-2485 (Aurora A inhibitor)Administered orally | Drug | JAB-2485 monotherapy, Phase 1, Dose Escalation |
| JAB-2485 (Aurora A inhibitor)Administered orally | Drug | JAB-2485 monotherapy, Phase 2a, Dose Expansion |
Primary outcome
Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
13 secondary outcomes
Dose Escalation phase: Objective Response Rate (ORR)
Time frame: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)
Dose Escalation and Dose Expansion phase: Time to response (TTR)
Time frame: Up to 3 years
Dose Escalation phase: Duration of Response (DOR)
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax)
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: time to peak plasma concentration(Tmax)
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: Ctrough
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: Area under the curve (AUC)
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: half-life (t½)
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: total body clearance
Time frame: Up to 3 years
Dose Expansion phase: Progression Free Survival (PFS)
Time frame: Up to 3 years
Dose Expansion Phase 2a: Overall Survival (OS)
Time frame: Up to 3 years
Dose Expansion phase: Disease Control Rate (DCR)
Time frame: Up to 3 years
Dose Expansion phase: Number of participants with adverse events (AEs)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JAB-2485 (Aurora A inhibitor) in people with Solid Tumors and ER+ Breast Cancer, run by Jacobio Pharmaceuticals Co., Ltd. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacobio Pharmaceuticals ((781) 918-6670, clinicaltrials@jacobiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs) (time frame: First 21 days of Cycle 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.