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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 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must be able to swallow and retain orally administered medication
Must not have
Clinically significant eye disorders
Active hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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I can swallow and keep down pills.
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My cancer is advanced and has been confirmed by lab tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have serious eye problems.
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I have active hepatitis B, hepatitis C, or HIV.
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I do not have any severe or uncontrolled health issues.
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I have side effects from treatment that are moderate or worse and not improving.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
20 Previous Clinical Trials
2,057 Total Patients Enrolled
Jacobio PharmaceuticalsStudy DirectorJacobio Pharmaceuticals
10 Previous Clinical Trials
994 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have serious eye problems.My organs are functioning well.You must have at least one detectable and measurable abnormality based on specific criteria.I am fully active or restricted in physically strenuous activity but can do light work.My brain metastases are stable with no growth or bleeding for at least 28 days.Your heart's pumping ability is less than 50% as measured by a special heart imaging test.I have active hepatitis B, hepatitis C, or HIV.You need to have a stored tumor sample available for testing.I have not been on antibiotics for an infection in the last week.My condition hasn't improved with current treatments.I can swallow and keep down pills.I do not have any severe or uncontrolled health issues.Your heart's QT interval is longer than 470 milliseconds.My cancer has a specific gene mutation or expression required for the trial.I have side effects from treatment that are moderate or worse and not improving.My cancer is advanced and has been confirmed by lab tests.
Research Study Groups:
This trial has the following groups:- Group 1: JAB-2485 monotherapy, Phase 1, Dose Escalation
- Group 2: JAB-2485 monotherapy, Phase 2a, Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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