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+/HER-2-/ER+ Breast Cancer
Summary
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
Detailed description
EP0062 is being investigated in this modular, interventional, open label, Phase 1/2 dose finding, optimisation and expansion study to determine the optimal dose of EP0062 given as monotherapy and for evaluation in combination with standard-of-care therapies in patients with Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer. Module A (phase 1 dose finding) has completed and an optimal dose has been selected for module B (phase 2 expansion).
Arms & interventions
- DrugEP0062
EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)
- DrugElacestrant
Oral SERD
- DrugEverolimus
mTOR Inhibitor
- DrugAbemaciclib
CDK4/6 inhibitor
- DrugFulvestrant
Oral SERD
- DrugExemestane
aromatase inhibitor
Outcome measures
Primary
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatment
Module A
Time frame: first 28 days
Maximum tolerated dose (MTD) and doses for evaluation in the expansion cohorts
Module A
Time frame: 1 year
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
Recommended clinical (dose (s) for combination therapy
Module B
Time frame: 1 year
Secondary
Plasma pharmacokinetic (PK) parameters - Half life
Time frame: 1, 2, 4, 8, 24 and 48 hours during cycle 1
Plasma pharmacokinetic (PK) parameters - Cmax
Time frame: 1, 2, 4, 8, 24 and 48 hours during cycle 1
Plasma pharmacokinetic (PK) parameters - Area under the curve (exposure)
Time frame: 1, 2, 4, 8, 24 and 48 hours during cycle 1
Tumour response
Time frame: screening and every 8 weeks up to 12 months
Clinical Benefit Rate (CBR)
Time frame: every 8 weeks up to 12 months
Objective Response Rate (ORR)
Time frame: every 8 weeks up to 12 months
Duration of Response (DOR)
Time frame: every 8 weeks up to 12 months
Progression-free survival (PFS)
Time frame: every 8 weeks up to 12 months
Overall Survival (OS)
Time frame: every 8 weeks up to 12 months
Relationship between EP0062 efficacy parameters and the level of Androgen Receptor expression and Androgen Receptor : Oestrogen Receptor ratio
Time frame: every 8 weeks up to 12 months
Eligibility criteria
Study locations (7)
Yale School of Medicine
New Haven, Connecticut, 06520
Moffitt Cancer Center
Tampa, Florida, 33612
Massachusetts General Hospital
Boston, Massachusetts, 02114
Henry Ford Hospital
Detroit, Michigan, 48202
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Texas Oncology Baylor University Medical Center
Dallas, Texas, 75246
Virginia Cancer Specialists
Fairfax, Virginia, 22031