JAB-2485 for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Disqualifiers: CNS metastases, Active infection, Hepatitis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

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.

Inclusion Criteria

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.

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Exclusion Criteria

I have serious eye problems.

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.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation of JAB-2485 will be administered as monotherapy to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).

Up to 3 years

Dose Expansion

JAB-2485 will be administered as monotherapy in patients with specific tumor types to evaluate the preliminary antitumor activity.

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

JAB-2485 (Aurora A inhibitor)

Trial OverviewThe 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.

Participant Groups

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.