EP0062 for Advanced Breast Cancer

Recruiting at 14 trial locations

Overseen By Clinical Trials Team

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Ellipses Pharma

Must not be taking: Testosterone, Antiandrogens, CYP3A4 inhibitors

Disqualifiers: Chemotherapy, Radiation, Heart conditions, others

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

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Vosilasarm (EP0062) for advanced breast cancer that has either recurred or spread. Researchers aim to determine the optimal dose of Vosilasarm and evaluate its effectiveness alone or with other standard treatments. The study targets patients with AR+ (androgen receptor positive), HER2- (human epidermal growth factor receptor 2 negative), and ER+ (estrogen receptor positive) cancer. It is suitable for postmenopausal women whose breast cancer has progressed after standard hormone therapies. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

The trial requires stopping certain medications before starting the study drug. You must stop chemotherapy 21 days before, tamoxifen and aromatase inhibitors 14 days before, and certain other drugs like testosterone and antiandrogens. If you're on medications that affect the heart's rhythm or interact with the study drug, you may need to stop those as well.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Vosilasarm (EP0062) is generally safe and well-tolerated. In earlier studies, patients handled the treatment well, even after receiving many other treatments. The treatment proved safe at doses between 50 mg and 100 mg per day. While some side effects occurred, they were manageable and not serious. This evidence suggests that Vosilasarm is well-tolerated, making it a reasonable option for those considering joining clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Vosilasarm for advanced breast cancer because it works differently from traditional treatments like hormone therapies and chemotherapy. Vosilasarm is a selective androgen receptor modulator (SARM), which targets androgen receptors in breast cancer cells, potentially offering a new way to inhibit tumor growth. Additionally, when combined with standard therapies like elacestrant and everolimus, Vosilasarm might enhance the effectiveness of these treatments, providing a promising option for patients who have not responded well to current therapies.

What evidence suggests that this trial's treatments could be effective for advanced breast cancer?

Research has shown that vosilasarm (EP0062) may benefit patients with advanced breast cancer. Earlier studies found vosilasarm to be safe and well-tolerated by patients who had already tried many treatments. The treatment demonstrated clinical benefits, improving conditions in some patients. In this trial, vosilasarm is tested in different treatment arms: one involves vosilasarm alone, while others combine it with standard treatments like elacestrant and everolimus. These combinations aim to enhance effectiveness. Although more research is needed, early results offer hope for those facing this challenging condition. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had both of my ovaries surgically removed.

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

I am over 60 years old.

Exclusion Criteria

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

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

Patients with any of the following will not be included in the study:

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding (Module A)

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

1 year

Multiple visits as per cohort assignment

Expansion (Module B)

Vosilasarm in combination with standard-of-care therapies (elacestrant or everolimus) to evaluate safety and efficacy

1 year

3-6 patients enrolled, with possible expansion up to 25 patients

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EP0062

Trial Overview

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.

How Is the Trial Designed?

Group I: Module B - Vosilasarm+ standard of care targeted therapy (everolimus) Experimental Treatment 2 Interventions

3-6 patients enrolled, with possible expansion up to 25 patients.

Group II: Module B - Vosilasarm+ standard of care targeted therapy (elacestrant). Experimental Treatment 2 Interventions

3-6 patients enrolled, with possible expansion up to 25 patients.

Group III: Module A - Vosilasarm Dose Finding Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Ellipses Pharma

Lead Sponsor

Trials

5

Recruited

430+

Published Research Related to This Trial

In a five-year pilot study involving 14 patients with advanced prostate cancer, pharmacological more complete androgen blockade (mMAB) demonstrated significant efficacy, with 7 out of 11 patients achieving a complete response after treatment.

The treatment was well-tolerated, with low and moderate side effects that did not require discontinuation of therapy, indicating a favorable safety profile for mMAB in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot attempt of advanced prostate cancer treatment T3NxMx-1 by intermittent more complete androgen blockade. Dutkiewicz, S.[2019]

Third-generation aromatase inhibitors (AIs) like anastrozole, letrozole, and exemestane have emerged as effective alternatives to tamoxifen for treating postmenopausal breast cancer, particularly in hormone receptor-positive cases, as shown in the ATAC trial with over five years of follow-up.

Fulvestrant, a new type of estrogen receptor antagonist with no partial agonist activity, represents a promising option in breast cancer treatment, and the review discusses future sequencing strategies for using AIs earlier in treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in the treatment of postmenopausal breast cancer. Howell, A.[2018]

In patients with advanced breast or prostate cancer, treatment with the LH-RH-agonist ICI 118630 resulted in a chemical castration-like response, indicating effective hormonal manipulation.

This response was associated with clinical remission of the disease in all treated patients, suggesting that ICI 118630 may be a promising therapeutic option for managing advanced hormone-sensitive cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of LH-RH agonists on the growth and hormonal environment of breast and prostate cancer. Nicholson, RI., Walker, KJ.[2013]

In a study of 19 patients with advanced breast cancer resistant to tamoxifen, 69% responded positively to the new antioestrogen ICI 182780, with a median response duration of 18 months and minimal side effects.

ICI 182780 shows promise as a treatment option for breast cancer, as it appears to have no agonist activity and does not adversely affect the liver or the hypothalamic-pituitary axis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response to a specific antioestrogen (ICI 182780) in tamoxifen-resistant breast cancer. Howell, A., DeFriend, D., Robertson, J., et al.[2019]

Hormonal treatments, particularly tamoxifen and medroxyprogesterone acetate, are standard initial therapies for early-stage ER-positive breast cancer, showing a response rate of 20-30% and a median duration of response of 6-10 months.

New hormonal agents, including LH-RH analogues for premenopausal patients and aromatase inhibitors for postmenopausal patients, are being developed and show promise in improving treatment outcomes, especially after tamoxifen failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recent advance of hormonal treatment for breast cancer]. Koyama, H., Inaji, H., Noguchi, S., et al.[2013]

In a large multinational trial (P024) involving postmenopausal women with hormone receptor-positive (HR+) breast cancer, neoadjuvant letrozole showed a significantly higher overall response rate (55%) compared to tamoxifen (36%), leading to more patients being eligible for breast-conserving surgery.

Letrozole was also more effective in reducing tumor proliferation and showed superior efficacy in both estrogen receptor-positive tumors and HER2+ subgroups, indicating its potential as a safer and more effective treatment option for HR+ locally advanced breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Letrozole in the neoadjuvant setting: the P024 trial. Ellis, MJ., Ma, C.[2021]

In a phase I clinical trial involving 53 premenopausal patients with advanced breast cancer, the luteinising hormone-releasing hormone agonist Zoladex showed a response rate of 31%.

The estrogen receptor (ER) status of the primary tumor was found to be a predictive factor for the response to Zoladex treatment, indicating that patients with ER-positive tumors may benefit more from this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of an LH-RH agonist (ICI 118630, Zoladex) in advanced premenopausal breast cancer. Williams, MR., Walker, KJ., Turkes, A., et al.[2019]

A 51-year-old woman with hormone receptor-positive breast cancer experienced a 43% reduction in tumor volume after receiving subcutaneous testosterone-letrozole implants before starting chemotherapy, indicating a positive response to this treatment.

The combination of testosterone-letrozole implants with chemotherapy led to a complete pathologic response in the tumor, and the patient tolerated the chemotherapy well without significant side effects, suggesting this approach could enhance treatment outcomes and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous testosterone-letrozole therapy before and concurrent with neoadjuvant breast chemotherapy: clinical response and therapeutic implications. Glaser, RL., York, AE., Dimitrakakis, C.[2018]

Third-generation aromatase inhibitors, such as letrozole, anastrozole, and exemestane, are effective and well-tolerated treatments for postmenopausal women with hormone-sensitive metastatic or locally advanced breast cancer.

These inhibitors are not only beneficial as first or second-line treatments but also serve as valuable options in neoadjuvant therapy and for localized tumors in women who cannot undergo surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary hormone treatment in postmenopausal women with breast cancer. Maciá Escalante, S., Pons Sanz, V., Rodríguez Lescure, A., et al.[2019]

Citations

1.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.1057

Results of a phase 1 study of vosilasarm (EP0062), a first- ...

Vosilasarm has promising clinical benefit, safety and tolerability in this heterogeneous, heavily pre-treated population.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05573126

Phase 1/2 Study to Evaluate Vosilasarm (EP0062) as ...

The aim of this study is to identify the optimal dose for Vosilasarm (EP0062) as monotherapy and in combination with standard-of-care therapies.

3.

withpower.com

withpower.com/trial/ep0062-for-advanced-breast-cancer-7c682

EP0062 for Advanced Breast Cancer

The aim of this study is to identify the optimal dose for Vosilasarm (EP0062) as monotherapy and in combination with standard-of-care therapies to assess ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1526820921002408

A First-in-Human Phase 1 Study of a Novel Selective ...

The purpose of this first-in-human phase 1 study was to characterize the safety, tolerability, maximum tolerated dose (MTD), recommended dose for expansion (RDE) ...

5.

consensus.app

consensus.app/search/how-has-testolone-rad140-improved-patient-outcomes/RvZMJoo1SRywLJ4XRUlkqg/

How has Testolone (RAD140) improved patient outcomes?

... advanced breast cancer, but patient outcomes have been modest and side effects are common. There is no evidence of broad clinical benefit or improved outcomes ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03088527

NCT03088527 | Phase 1, First-in-Human Study of RAD140 ...

The primary purpose of this study is to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone ...