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Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer

ConditionsHormone Receptor-positive Breast CancerHormone Receptor Positive HER-2 Negative Breast CancerMetastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEllipses Pharma

About this trial

The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women 18 years or older at the time of informed consent

Histologically proven diagnosis of breast cancer with evidence of metastatic or locally advanced breast adenocarcinoma as defined by the American Joint Committee on Cancer/Union for International Cancer Control/Tumour Node Metastases (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

Availability of archival tumour sample (formalin-fixed, paraffin-embedded block(s) or slides from a primary tumour or biopsy of a metastatic tumour lesion or lesions); in the absence of an archival tumour sample, or if only archival bone tissue is available, a fresh biopsy will need to be collected

Biopsy-proven AR+ and ER+ breast cancer

Disqualifiers

Any chemotherapy within 21 days prior to the first dose of study drug

Any non-chemotherapy investigational anti-cancer drug < 5 half-lives (28 days for biologics) or < 14 days for small-molecule therapeutics or if half-life is not known

Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug

Fulvestrant or other investigational Selective Estrogen Receptor Degraders (SERDs) within 21 days prior to first dose of study drug

Trial design

Design model

Sequential

Treatments tested in this trial

  • EP0062

    Drug

    EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)

  • Elacestrant

    Drug

    Oral SERD

  • Everolimus

    Drug

    mTOR Inhibitor

  • Abemaciclib

    Drug

    CDK4/6 inhibitor

  • Fulvestrant

    Drug

    Oral SERD

  • Exemestane

    Drug

    aromatase inhibitor

Treatment groups

95 Participants
are divided into 4 treatment groups
Group A: Module A - EP0062 Dose FindingExperimental treatment 1 intervention
Group B: Module B - EP0062+ standard of care targeted therapy (elacestrant).Experimental treatment 2 interventions
Group C: Module B - EP0062+ standard of care targeted therapy (everolimus/exemestane)Experimental treatment 3 interventions
Group D: Module B: EP0062 in combination with Abemaciclib and FulvestrantExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Module A

Time frame
first 28 days
2

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

Module A

Time frame
1 year
3

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Module A/B

Time frame
up to 30 days after the end of treatment
4

Recommended clinical (dose (s) for combination therapy

Module B

Time frame
1 year

Secondary outcomes

1

Plasma pharmacokinetic (PK) parameters - Half life

Time frame
1, 2, 4, 8, 24 and 48 hours during cycle 1
2

Plasma pharmacokinetic (PK) parameters - Cmax

Time frame
1, 2, 4, 8, 24 and 48 hours during cycle 1
3

Plasma pharmacokinetic (PK) parameters - Area under the curve (exposure)

Time frame
1, 2, 4, 8, 24 and 48 hours during cycle 1
4

Tumour response

Time frame
screening and every 8 weeks up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ellipses Pharma

Lead sponsor

Source ClinicalTrials.gov
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