Study on Oral PMD-026 for Patients with Metastatic Breast Cancer
Sponsor: Phoenix Molecular Designs
ClinicalTrials ID:NCT04115306
This clinical trial is testing a new oral medication, PMD-026, to see if it is safe and can be tolerated by patients with metastatic breast cancer. The medication is designed to target and kill cancer cells.
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Program Overview
The study aims to evaluate the safety and tolerability of PMD-026, an oral medication, in patients with metastatic breast cancer. PMD-026 is specifically designed to target and destroy cancer cells in this type of breast cancer.
Description
This study involves testing PMD-026 in combination with another medication called fulvestrant. It will include patients whose cancer is hormone receptor-positive (HR+) and does not have the HER2 protein (HER2-). These patients must have already been treated with a CDK4/6 inhibitor and hormone therapy.
Fulvestrant will be given as an injection according to its standard dosing schedule, while PMD-026 will be taken orally at a dose determined in earlier study phases. Up to 20 patients with advanced or metastatic HR+/HER2- breast cancer will participate.
Initially, 6 patients will receive the combination treatment to ensure it is safe. If no major safety concerns arise, an additional 14 patients will be included, making a total of 20 participants. The study will use a specific safety monitoring method to check for any serious side effects during the trial.
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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