Open
Actively Recruiting
Phase 1/1b/2 Study of Oral PMD-026 in Patients with Metastatic Breast Cancer
About
Brief Summary
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria, Combination with fulvestrant (Part 3):
- Available archival or FFPE
- RSK2 positive (≥75% nuclear staining with ≥2+ in staining intensity) as assessed by central lab from available archival or fresh tumor tissue (FFPE).
- Histologically or cytologically diagnosed HR+, HER2- defined as both
- >1% expression of ER and/or PgR receptor
- ≤ 1+ by IHC for HER2, or FISH negative. If 2+ by IHC for HER2 combined with FISH negative
- 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
- Has not received fulvestrant in the locally advanced or metastatic setting. Note: If prior to study entry, a patient initiates fulvestrant in combination with targeted therapy and becomes intolerant of the targeted therapy before progression, that patient may enroll if PMD-026 is initiated within 48 days of start of fulvestrant and no missed doses of fulvestrant occurred.
- Not eligible for an AKT or PI3K inhibitor
- 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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Study Stats
Protocol No.
20-001187
Category
Breast Cancer
Principal Investigator
Contact
Location
- UCLA Alhambra
- UCLA Burbank
- UCLA Encino
- UCLA Parkside
- UCLA Pasadena
- UCLA San Luis Obispo
- UCLA Santa Clarita
- UCLA Santa Monica
- UCLA Ventura
- UCLA Westwood