Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer

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

  • Metastatic Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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.