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Aurora A inhibitor

JAB-2485 for Advanced Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Jacobio Pharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have adequate organ functions
Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trialtests a new treatment for adults with advanced cancer to see if it is safe and tolerable.

Who is the study for?
Adults with advanced solid tumors, including specific types of breast and small cell lung cancer, can join if they're in good physical condition (ECOG 0 or 1), have tried all other treatments without success, and have at least one tumor that can be measured. They must be able to take pills and provide a sample of their tumor. People with weak hearts, active hepatitis or HIV, brain metastases not stable for over a month, recent infections needing treatment, significant eye problems or uncontrolled medical conditions cannot participate.Check my eligibility
What is being tested?
The trial is testing JAB-2485 alone to see how safe it is for patients with advanced cancers. It's an Aurora A inhibitor—a type of drug that interferes with certain proteins in cancer cells to stop them from growing.See study design
What are the potential side effects?
While the exact side effects are being studied, drugs like JAB-2485 may cause fatigue, nausea, diarrhea; blood count changes affecting immunity; liver enzyme alterations; heart rhythm changes; and could potentially affect vision due to its mechanism.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs are functioning well.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My condition hasn't improved with current treatments.
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I can swallow and keep down pills.
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My cancer has a specific gene mutation or expression required for the trial.
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My cancer is advanced and has been confirmed by lab tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Escalation phase: Number of participants with adverse events (AEs)
Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
Dose Expansion phase: Duration of Response (DOR)
+1 more
Secondary outcome measures
Dose Escalation and Dose Expansion phase: Area under the curve (AUC)
Dose Escalation and Dose Expansion phase: Ctrough
Dose Escalation and Dose Expansion phase: Time to response (TTR)
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: JAB-2485 monotherapy, Phase 2a, Dose ExpansionExperimental Treatment1 Intervention
JAB-2485 will be administered as monotherapy in patients with specific tumor types to evaluate the preliminary antitumor activity.
Group II: JAB-2485 monotherapy, Phase 1, Dose EscalationExperimental Treatment1 Intervention
Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D.

Find a Location

Who is running the clinical trial?

Jacobio Pharmaceuticals Co., Ltd.Lead Sponsor
18 Previous Clinical Trials
1,468 Total Patients Enrolled
2 Trials studying Breast Cancer
48 Patients Enrolled for Breast Cancer
Jacobio PharmaceuticalsStudy DirectorJacobio Pharmaceuticals
9 Previous Clinical Trials
616 Total Patients Enrolled
1 Trials studying Breast Cancer
24 Patients Enrolled for Breast Cancer

Media Library

JAB-2485 (Aurora A inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05490472 — Phase 1 & 2
Breast Cancer Research Study Groups: JAB-2485 monotherapy, Phase 1, Dose Escalation, JAB-2485 monotherapy, Phase 2a, Dose Expansion
Breast Cancer Clinical Trial 2023: JAB-2485 Highlights & Side Effects. Trial Name: NCT05490472 — Phase 1 & 2
JAB-2485 (Aurora A inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05490472 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively receiving treatment in this trial?

"Affirmative. Clinicaltrials.gov's records reflect that this research is actively searching for participants, having been initially posted on December 20th 2022 and updated most recently January 4th 2023. The study requires 102 individuals to be admitted into the two sites in question."

Answered by AI

Are there any remaining spots available for this clinical research?

"Affirmative. Data hosted on clinicaltrials.gov suggests that this medical trial, initially shared on December 20th 2022, is currently looking for patients to enrol in the study. 102 individuals must be recruited from two different healthcare centres."

Answered by AI

What are the aims of this experiment?

"The main efficacy marker of this clinical trial, to be monitored within the initial 21 days of Cycle 1, is the number of participants with adverse events (AEs). Secondary endpoints include: peak plasma concentration (Cmax) as part of PK analyses and assessing food effect on JAB-2485 monotherapy in conjunction with urine or plasma samples; time to response (TTR), recorded from the first treatment to documented complete or partial responses according to RECIST v1.1 criteria; and objective response rate (ORR), measured by percentage of participants who achieved a complete/partial remission under RECIST v1.1 parameters."

Answered by AI
~21 spots leftby Aug 2024