Testing a new oral medication for metastatic breast cancer
Ph 1/1b/2 Multicenter, Open-Label, FIH Dose Esc & Dose Exp Study to Assess Safety and Tolerability of Orally Administered PMD-026 as a Single Agent and in Combination in Patients With Metastatic or Locally Advanced (Inoperable) RSK2+ Breast Cancer
This study is testing a new oral medication for people with hormone receptor-positive, HER2-negative metastatic breast cancer to see if it works better when combined with a standard treatment they’ve already had.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 61 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Phoenix Molecular Designs Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 11 sites (Gilbert, Arizona and 10 other locations) |
| Trial ID | NCT04115306 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of PMD-026, a targeted oral agent, in patients with metastatic breast cancer. It specifically focuses on patients with hormone receptor-positive, HER2-negative breast cancer who have previously been treated with a CDK4/6 inhibitor. The study will assess the effectiveness of PMD-026 in combination with fulvestrant, a standard endocrine therapy, to determine the optimal dosage and treatment regimen. Up to 20 patients will be enrolled to gather data on this combination therapy's impact on tumor progression.
Who should consider this trial
Good fit: Ideal candidates include those with RSK2 positive, hormone receptor-positive, HER2-negative metastatic breast cancer who have previously received endocrine therapy.
Not a fit: Patients with HER2-positive breast cancer or those who have not received prior endocrine therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced breast cancer that is resistant to current therapies.
How similar studies have performed: Other studies have shown promise with similar targeted therapies in metastatic breast cancer, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria, Combination with fulvestrant (Part 3): * RSK2 positive from available archival or fresh tumor tissue (FFPE). * Histologically or cytologically diagnosed HR+, HER2- * ESR1 wild type * 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): * Prior chemotherapy * ESR1 mutations * ≤14 days from biological or investigational therapy * 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)
Where this trial is running
Gilbert, Arizona and 10 other locations
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (Recruiting)
- City of Hope — Duarte, California, United States (Recruiting)
- City of Hope Orange County, Lennar — Irvine, California, United States (Recruiting)
- University of California, Los Angeles (UCLA) — Los Angeles, California, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- City of Hope Chicago — Zion, Illinois, United States (Recruiting)
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (Recruiting)
- Profound Research — Farmington Hills, Michigan, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- Oncology Consultants — Houston, Texas, United States (Withdrawn)
- South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Phoenix Molecular Designs PMD
- Email: clinical@phoenixmd.ca
- Phone: (858) 945-6456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.