Purpose

The purpose of this study is to test the safety and tolerability of PMD-026 in patients with metastatic breast cancer. PMD-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

, Combination with fulvestrant (Part 3): - RSK2 positive from available archival or fresh tumor tissue (FFPE). - Histologically or cytologically diagnosed HR+, HER2- - Diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amendable to resection or radiation with curative intent or metastatic disease not amendable to curative therapy - Must be appropriate candidates for endocrine therapy - Previously received at least 1 line of endocrine therapy for MBC or had recurrence while on adjuvant endocrine therapy for locally advanced breast cancer - Discontinued endocrine therapy at least 15 days prior to first dose of PMD-026 - At least 1 measurable target lesion as defined by RECIST v1.1 - Progression on or after treatment with a CDK4/6 inhibitor in combination with endocrine therapy inhibitor in the locally advanced or metastatic setting - Adequate hematologic, hepatic, and renal function as assessed by laboratory parameters - Toxicity related to prior therapy resolved to at least Grade 1 (alopecia excepted) or to at least Grade 2 with prior approval of the Medical Monitor

Exclusion Criteria

, Combination with fulvestrant (Part 3): - ≤14 days from prior chemotherapy, biological or investigational therapy - Prior fulvestrant in the locally advanced or metastatic setting - Presence of visceral crisis or uncontrolled visceral disease for which chemotherapy would be indicated - Central nervous system metastases, unless appropriately treated and neurologically stable - History of leptomeningeal metastases - Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy - Known hepatitis B or hepatitis C infection - Known HIV-positive with CD4+ cell counts <350 cells/μL - Known HIV-positive with a history of an AIDS-defining opportunistic infection - History of clinically significant cardiovascular abnormalities, including QTcF interval >460 msec (using Fridericia's formula)

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Oral PMD-026 in combination with fulvestrant
Daily dosing of PMD-026 with fulvestrant dosing according to package insert
  • Drug: PMD-026
    Investigational Drug
  • Drug: fulvestrant
    SERDs
    Other names:
    • Faslodex

Recruiting Locations

Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
Contact:
Natalie Moffett
617-724-1864
nmoffett@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Phoenix Molecular Designs

Study Contact

Phoenix Molecular Designs PMD
(858) 945-6456
clinical@phoenixmd.ca

Detailed Description

Combination with fulvestrant (Part 3): This study will prospectively enroll RSK2+, HR+, and human epidermal growth factor receptor 2 negative (HER2-) patients to evaluate PMD-026 in combination with a standard dose and schedule of fulvestrant. Fulvestrant will be dosed per the package insert in combination with PMD-026 at the RP2D determined in the monotherapy phase of the study. Up to 20 patients will be enrolled with locally advanced or metastatic HR+/HER2- breast cancer previously treated with a CDK4/6 inhibitor in combination with endocrine therapy.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.