JAB-2485 for Advanced Cancer

Recruiting at 10 trial locations

Overseen By Jacobio Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Disqualifiers: CNS metastases, Active infection, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JAB-2485 for people with advanced solid tumors. The focus is on assessing the treatment's safety, tolerability, and potential to fight cancer. It consists of two phases: the first determines the optimal dose, and the second evaluates its effectiveness against specific tumor types. This trial suits those with a confirmed diagnosis of an advanced solid tumor who have not succeeded with other treatments. Participants should not have certain infections or severe medical conditions and must be able to take oral medication. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects on people.

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.

Is there any evidence suggesting that JAB-2485 is likely to be safe for humans?

Research has shown that JAB-2485, a new treatment for advanced cancer, has a promising safety record from earlier studies. Preclinical tests found that JAB-2485 was well-tolerated and had fewer side effects compared to similar treatments, suggesting it might be safer for people.

Another study found that JAB-2485 effectively stopped cancer cells from growing in lab tests. Although not yet tested in humans, these results are encouraging for its safety and effectiveness.

Since this trial is in the early stages, the main focus is to ensure JAB-2485 is safe for people. While some unknowns remain, the information so far appears positive for its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JAB-2485 for advanced cancer because it offers a novel approach by targeting specific tumor types as a monotherapy, unlike traditional chemotherapy that broadly attacks both cancerous and healthy cells. Most standard treatments for advanced cancer, like chemotherapy or radiation, can have widespread effects on the body, leading to significant side effects. JAB-2485 specifically aims to determine the maximum tolerated dose and assess preliminary antitumor activity, potentially leading to more effective and targeted cancer control with fewer side effects. This precision in targeting tumors could represent a significant advancement over existing therapies, offering hope for improved patient outcomes.

What evidence suggests that JAB-2485 might be an effective treatment for advanced cancer?

Research shows that JAB-2485, a new treatment under investigation in this trial, has demonstrated promising results in early studies for treating cancer. It targets a protein called AURKA, which aids cancer cell growth. In lab tests, JAB-2485 stopped cancer cells from dividing and caused them to die, especially in small cell lung cancer and triple-negative breast cancer. The treatment appears more effective and safer than similar drugs, particularly when the RB gene is missing. These early findings suggest that JAB-2485 could be a viable option for people with advanced solid tumors. Participants in this trial will receive JAB-2485 as monotherapy, with the trial including both a Phase 1 dose escalation to determine the maximum tolerated dose and a Phase 2a dose expansion to evaluate preliminary antitumor activity. ^{1 3 4 5 6}

Who Is on the Research Team?

Jacobio Pharmaceuticals

Principal Investigator

Jacobio Pharmaceuticals

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• JAB-2485

Trial Overview 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.

How Is the Trial Designed?

Group I: JAB-2485 monotherapy, Phase 2a, Dose Expansion Experimental Treatment 1 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 Escalation Experimental Treatment 1 Intervention

Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D.

Who Is Running the Clinical Trial?

Jacobio Pharmaceuticals Co., Ltd.

Lead Sponsor

Trials

21

Recruited

2,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11097369/

Preclinical Evaluation of JAB-2485, a Potent AURKA ... As a single agent, JAB-2485 effectively induced G2/M cell cycle arrest and apoptosis and inhibited the proliferation of small cell lung cancer, triple-negative ...

2. pubs.acs.org pubs.acs.org/doi/10.1021/acsomega.4c01752

Preclinical Evaluation of JAB-2485, a Potent AURKA Inhibitor ... As a single agent, JAB-2485 effectively induced G2/M cell cycle arrest and apoptosis and inhibited the proliferation of small cell lung cancer, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05490472

Study Details | NCT05490472 | JAB-2485 Activity in Adult ... 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 ...

4. jacobiopharma.com jacobiopharma.com/en/pipeline/aurora-a

Aurora A Inhibitor | Jacobio Pharma Preclinical data have shown that JAB-2485 has enhanced efficacy and safety over other AURKA inhibitors, enhanced in the setting of retinoblastoma (RB) gene loss ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)03679-2/pdf

689TiP A phase I/IIa trial of Aurora-A inhibitor (JAB-2485) ... JAB-2485 efficiently induced G2/M phase cell cycle arrest and apoptosis of cancer cells in vitro.

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)03679-2/fulltext

689TiP A phase I/IIa trial of Aurora-A inhibitor (JAB-2485) ... JAB-2485 efficiently induced G2/M phase cell cycle arrest and apoptosis of cancer cells in vitro. Furthermore, it showed impressive anti-tumor efficacy both as ...