EP0031 for Cancer

Recruiting at 40 trial locations

Overseen ByArturo Maldonado

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ellipses Pharma

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Brain metastases, Active infection, HIV, others

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

Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called EP0031 to determine its safety and effectiveness for people with certain advanced cancers involving changes in the RET gene. It targets individuals with non-small cell lung cancer (NSCLC) and other solid tumors affected by these gene changes. Participants will take EP0031 capsules daily to assess any benefits or side effects. The trial seeks individuals with RET-altered cancers who have tried other treatments and are still searching for options. As a Phase 1 and Phase 2 trial, it aims to understand how EP0031 works in people and measure its effectiveness in an initial group, offering participants early access to a potentially beneficial treatment.

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

The trial does not specify if you need to stop your current medications, but you cannot participate if you are taking any strong inhibitors or inducers of CYP3A4 (a liver enzyme that processes drugs). It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that EP0031 is likely to be safe for humans?

Research shows that EP0031 is generally well-tolerated by patients with certain types of cancer. Studies have found that this treatment is safe for individuals with RET fusion-positive non-small cell lung cancer (NSCLC), even for those with additional complications like brain metastases.

For RET mutation-positive medullary thyroid cancer (MTC), research also indicates that EP0031 is safe, with safety profiles similar to those observed in NSCLC patients.

In other cancers with RET alterations, EP0031 has demonstrated promising safety results. Patients typically experienced manageable side effects, akin to those from other treatments for RET-altered cancers.

Overall, EP0031 appears to be a safe option for people with these types of cancers, although, like any treatment, it can have side effects. Evidence so far suggests these side effects are manageable.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about EP0031 because it targets RET alterations in various cancers, including RET fusion-positive non-small cell lung cancer (NSCLC) and RET mutation-positive medullary thyroid cancer (MTC). Unlike standard treatments such as first-generation selective RET inhibitors, EP0031 is designed to be more specific in its action, potentially reducing side effects and improving effectiveness. Additionally, EP0031 is administered as a daily capsule, which could offer more convenience compared to existing therapies that might require more complex delivery methods. The hope is that EP0031 will provide a new option for patients who have developed resistance to current treatments or for those who have not received prior selective RET inhibitors.

What evidence suggests that EP0031 could be an effective treatment for advanced RET-altered malignancies?

Research has shown that EP0031 is promising for treating advanced cancers with RET changes, such as certain lung and thyroid cancers. In this trial, participants with RET fusion-positive non-small cell lung cancer (NSCLC), RET mutation-positive medullary thyroid cancer (MTC), and other RET-altered solid tumors will receive EP0031. Studies have found that EP0031 has manageable side effects and early signs of effectiveness in patients with a specific type of lung cancer, even if it has spread to the brain. For thyroid cancer with RET mutations, EP0031 demonstrated good tolerance and safety. In other solid tumors with RET changes, EP0031 led to lasting improvements in patients who had tried other treatments. These findings suggest that EP0031 could effectively treat these specific cancer types.² ³ ⁵ ⁶ ⁷

Are You a Good Fit for This Trial?

Adults over 18 with advanced RET-altered malignancies can join this trial. They should understand their treatment options and be in good physical condition (ECOG status of 0 or 1). Exclusions include active infections needing drugs, severe health issues, certain liver/kidney conditions, recent heart problems, uncontrolled blood pressure, brain metastases unless stable.

Inclusion Criteria

Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures

I am fully active or restricted in physically strenuous activity but can do light work.

I am fully informed about my treatment options, including RET-targeted therapies.

Exclusion Criteria

I am currently on medication for an active infection.

My liver, kidneys, or bone marrow do not work properly.

I have an active hepatitis B or C infection.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EP0031 capsules at the recommended Phase II dose until progressive disease, unacceptable toxicity, or patient withdrawal

Until disease progression or withdrawal

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

EP0031

Trial Overview The study is testing EP0031's safety and effectiveness for tumors with specific genetic changes called 'RET alterations'. It will look at how well patients respond to the drug and what side effects occur.

How Is the Trial Designed?

6Treatment groups

Experimental Treatment

Group I: RET mutation-positive MTC (prior 1st gen SRI)Experimental Treatment1 Intervention