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

Sponsor: Phoenix Molecular Designs

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04115306

Patient View

This study evaluates the safety of PMD-026 with fulvestrant in RSK2+ HR+/HER2- metastatic breast cancer patients. Up to 20 patients, previously treated with CDK4/6 inhibitors, will receive PMD-026 (200 mg, PO, Q12h) and fulvestrant (500 mg IM) per standard dosing. A safety lead-in cohort of 6 patients will be assessed before expanding to 20, using a Bayesian safety monitoring rule for DLTs.

Patient Parameters

Program Overview

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.

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.

Eligibility Criteria

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)

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