Authorised Phase I and Phase II (Integrated)- Other Breast Cancer

A Modular Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation, and Expansion Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of EP0062 as monotherapy and in combination in Patients with Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer

EU CTIS ID: 2023-507738-26-00

What this study is testing

Module A - Evaluate the safety and tolerability of EP0062 - Determine the optimal clinical dose(s) of the new formulation of EP0062 given as monotherapy and identify a dose for evaluation in the combination arms of Module B Module B - Evaluate the safety and tolerability of EP0062 in combination therapy

Phase I and Phase II (Integrated)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Women 18 years or older at the time of informed consent
2. Histologically proven diagnosis of breast cancer with evidence of metastatic or locally advanced breast adenocarcinoma as defined by the AJCC/UICC TNM staging classification (8th Ed, 2017) and where no conventional therapy is available or considered appropriate by the Investigator or is declined by the patient. Patients enrolled into the combination arms of Module B must be assessed by the investigator to qualify for treatment with the combination agent(s) as standard-of-care.
3. Biopsy-proven AR+ HER2- and ER+ breast cancer on a fresh biopsy from a primary tumour or metastatic tumour lesion. Where a fresh biopsy is not feasible, an archival tumour sample (formalin-fixed, paraffin embedded block(s) or slides can be used for this purpose providing they are not more than 10 years old. Hormonal analysis of cytology specimens e.g. malignant pleural effusion may be used to confirm receptor status. Retrospective confirmatory testing is allowed. 3.1 AR+ breast cancer is defined as ___ AR nuclei staining by IHC either locally by a CLIA-certified laboratory or centrally. The test should be performed in accordance with clinical guidelines delineated by ASCO, CAP and NCCN 3.2 HER2- breast cancer, defined as negative by immunohistochemistry (IHC) score of 0 or 1+. If IHC is equivocal at 2+, a negative in situ hybridisation (ISH) test (HER2/CEP17 ratio of <2.0) is required
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
5. Postmenopausal, based on protocol-defined criteria on page 56
6. Module A: Received ___ prior lines of endocrine therapy in advanced/metastatic setting, which may have included both an AI (alone or in combination) and SERD (alone or in combination); at least one must have been given in combination with a CDK 4/6 inhibitor. Module B: Patients must be a candidate for the combination agent(s) as standard-of-care treatment.

You likely can't join if

1. Prior anti-cancer or investigational drug treatment, within protocol-defined time windows on page 58
20. The patient is unable to swallow___ and/or has a surgical or anatomical condition that precludes swallowing and absorbing oral medication on an ongoing basis
21. Any other condition that would, in the Investigator’s judgement, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures
2. Prior treatment with Enobosarm
22. Patients receiving medications that are known to be strong inhibitors or inducers of CYP3A4 within 5 half-lives or 14 days, whichever is longer, before the first dose of study drug
23. Known active hepatitis B or C

See the full eligibility criteria

Who can join

1. Women 18 years or older at the time of informed consent
2. Histologically proven diagnosis of breast cancer with evidence of metastatic or locally advanced breast adenocarcinoma as defined by the AJCC/UICC TNM staging classification (8th Ed, 2017) and where no conventional therapy is available or considered appropriate by the Investigator or is declined by the patient. Patients enrolled into the combination arms of Module B must be assessed by the investigator to qualify for treatment with the combination agent(s) as standard-of-care.
3. Biopsy-proven AR+ HER2- and ER+ breast cancer on a fresh biopsy from a primary tumour or metastatic tumour lesion. Where a fresh biopsy is not feasible, an archival tumour sample (formalin-fixed, paraffin embedded block(s) or slides can be used for this purpose providing they are not more than 10 years old. Hormonal analysis of cytology specimens e.g. malignant pleural effusion may be used to confirm receptor status. Retrospective confirmatory testing is allowed. 3.1 AR+ breast cancer is defined as ___ AR nuclei staining by IHC either locally by a CLIA-certified laboratory or centrally. The test should be performed in accordance with clinical guidelines delineated by ASCO, CAP and NCCN 3.2 HER2- breast cancer, defined as negative by immunohistochemistry (IHC) score of 0 or 1+. If IHC is equivocal at 2+, a negative in situ hybridisation (ISH) test (HER2/CEP17 ratio of <2.0) is required
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
5. Postmenopausal, based on protocol-defined criteria on page 56
6. Module A: Received ___ prior lines of endocrine therapy in advanced/metastatic setting, which may have included both an AI (alone or in combination) and SERD (alone or in combination); at least one must have been given in combination with a CDK 4/6 inhibitor. Module B: Patients must be a candidate for the combination agent(s) as standard-of-care treatment.
7. Received ___ of chemotherapy in the advanced/metastatic setting.
8. Endocrine-therapy–sensitive breast cancer, defined as: a) greater than 2 years of adjuvant endocrine therapy prior to the development of advanced or metastatic disease, OR b) previous response (without disease progression for at least 6 months) to one of the following treatments in the advanced/metastatic setting: SERD +/- CDK 4/6 inhibitor, AI +/- CDK 4/6 inhibitor
9. Measurable disease, defined by Response Evaluation in Solid Tumours (RECIST) v1.1, or bone-only evaluable disease (e.g., with a blastic or lytic component that can be imaged)
10. Estimated life expectancy >3 months
11. In the opinion of the Investigator, all other relevant medical conditions must be well-managed and stable for at least 28 days prior to first administration of study drug
12. Adequate haematological and organ function, based on protocol-defined criteria on page 57
13. Left ventricular ejection fraction >50% (by echocardiogram or multi-gated acquisition [MUGA] scan)
14. Willing and able to participate in all required evaluations and procedures in this study protocol
15. Ability to understand and provide written informed consent before any study-specific procedures, sampling, or analyses, including access to archival tumour tissue
16. Combination Agents (Module B): All combination agents are established standard-of-care therapies and will be prescribed in accordance with their respective labels, local clinical practice and protocol inclusion-exclusion criteria. As such, any specific warnings, precautions and contraindications must be considered in addition to the inclusion-exclusion criteria.

What rules you out

1. Prior anti-cancer or investigational drug treatment, within protocol-defined time windows on page 58
20. The patient is unable to swallow___ and/or has a surgical or anatomical condition that precludes swallowing and absorbing oral medication on an ongoing basis
21. Any other condition that would, in the Investigator’s judgement, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures
2. Prior treatment with Enobosarm
22. Patients receiving medications that are known to be strong inhibitors or inducers of CYP3A4 within 5 half-lives or 14 days, whichever is longer, before the first dose of study drug
23. Known active hepatitis B or C
24. Patients with active human immunodeficiency virus (HIV) infection. Patients living with HIV are eligible if they have CD4+ T-cell count ≥ 350 cells/µL, no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the past 12 months, and can be managed on a regimen consistent with this protocol’s permitted concomitant medications
3. Currently taking testosterone, methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, testosterone-like agents (e.g., dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or antiandrogens
4. Radiation therapy within 14 days prior to the first dose of study drug. Short courses of palliative radiation therapy during the study might be allowed following discussion with and approval by the Medical Monitor.
5. 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
6. Symptomatic cerebral metastases or central nervous system (CNS) involvement, based on protocol-defined criteria on page 59
10. Congestive heart failure Grades III–IV according to the New York Heart Association at the time of screening
7. Confirmed QTcF > 470 ms on screening ECG, or history of torsades de pointes (TdP), or history of congenital long QT syndrome, or immediate family history of long QT syndrome, unexplained sudden death at a young age, or sudden cardiac death
8. Any other clinically important abnormalities in rhythm, conduction, or morphology on resting ECG (e.g., complete left bundle branch block, third-degree heart block); rate-controlled atrial fibrillation is permitted
9. 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
18. Received a live vaccine within 28 days prior to planned enrolment; combination module B-Arm 2 only
19. A history of (non-infectious) pneumonitis requiring steroids, or current pneumonitis; combination module B-Arm 2 only
11. Myocardial infarction or unstable angina within the previous 6 months
12. Any other concurrent severe and/or uncontrolled medical or surgical condition which, in the view of the Investigator, could compromise the patient’s participation in the study
13. Active infection requiring intravenous or oral antibiotics within 14 days before the first dose of study drug
14. Any major surgical procedure (planned or anticipated, in the Investigator’s judgement) within 14 days of the first dose of study drug
15. Known contraindications or hypersensitivity to SARMs or the excipients of the study drug
16. Known contraindications or hypersensitivity to combination agents or their excipients
17. Module B: Prior treatment with: –Arm 1: Standard treatment 1 –Arm 2: Standard treatment 2 –Arm 3: Standard treatment 3

The study team makes the final eligibility decision.

Where it's taking place

United States
United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.