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EP0062 for Advanced Breast Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Ellipses Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior bilateral oophorectomy

Amenorrhea > 12 months at the time of informed consent and an intact uterus, with follicle-stimulating hormone (FSH) and oestradiol in the postmenopausal ranges (as per local practice)

Must not have

Unresolved or unstable serious toxic side effects of prior chemotherapy or radiotherapy, i.e., ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except fatigue, alopecia, and Grade 2 chemotherapy-induced neuropathy

Concomitant medications that prolong the corrected QT interval and/or increase the risk for TdP that cannot be discontinued or substituted with another drug within 5 half-lives or 14 days before the first dose of study drug, whichever is longer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug to see if it's safe & effective in treating breast cancer that's spread or come back.

Who is the study for?

This trial is for postmenopausal women over 18 with AR+/HER2-/ER+ breast cancer that's advanced or metastatic and has no standard treatment options left. They must have a biopsy-proven diagnosis, be amenorrheic with an intact uterus, or have had a bilateral oophorectomy. Women under 55 who've had a hysterectomy must show postmenopausal hormone levels.

What is being tested?

The study tests EP0062 as a single therapy to find the best dose and evaluate its safety, tolerability, how the body processes it (pharmacokinetics), and effectiveness in patients with specific types of advanced breast cancer.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects for new cancer therapies may include nausea, fatigue, allergic reactions, blood count changes leading to increased infection risk or bleeding problems. Specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had both of my ovaries surgically removed.

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I have not had a period for over a year, and my hormone levels confirm I am postmenopausal.

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I am over 60 years old.

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My breast cancer is HER2-negative based on specific tests.

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My breast cancer is AR+ with at least 30% of cells showing AR by a specific test.

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I can provide a sample of my tumor, or I am willing to have a new biopsy if needed.

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My breast cancer is positive for both AR and ER.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have serious side effects from previous cancer treatments, except for tiredness, hair loss, or mild nerve pain.

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I am not on medications that affect heart rhythm and can't be stopped.

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I am currently on medications like testosterone or hormonal treatments.

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My heart condition is classified between moderate to severe.

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My heart's electrical activity is mostly normal, except for controlled atrial fibrillation.

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I have a heart condition related to abnormal ECG results or a family history of sudden cardiac death.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatment

Maximum tolerated dose (MTD) and doses for evaluation in the expansion cohorts

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Module B - EP0062 Dose level 2Experimental Treatment1 Intervention

Patients randomised to one of the 2 expansion doses selected from Module A, with up to 30 patients included per dose level, to further characterise the safety and efficacy of EP0062.

Group II: Module B - EP0062 Dose level 1Experimental Treatment1 Intervention

Patients randomised to one of the 2 expansion doses selected from Module A, with up to 30 patients included per dose level, to further characterise the safety and efficacy of EP0062.

Group III: Module A - EP0062 Dose FindingExperimental Treatment1 Intervention

Patients are assigned to dose level cohorts to identify MTD and assess safety, tolerability and PK profile.

0 / 13Eligibility criteria met