Phase 1/1b Multicenter, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 in Patients with Metastatic Breast Cancer with Expansion in Metastatic Triple Negative Breast Cancer
Determine the safety and tolerability of PMD-026
Determine the maximum tolerated dose (MTD) of PMD-026
Define a recommended phase 2 dose (RP2D) of PMD-026
Assess anti-tumor activity of PMD-026 in patients with TNBC
Part 1 - Dose Escalation: Histologically or cytologically diagnosed metastatic breast cancer that has progressed on or after standard of care therapy and for which no standard of care therapy is available that would confer clinical benefit
Part 2 - Dose Expansion: Histologically or cytologically diagnosed metastatic triple-negative breast cancer with 1% expression of ER and PR and negative for HER2 (either 0 to 1+ by IHC or IHC2+ and fluorescence in situ hybridization (FISH) negative) from the time of initial diagnosis that has progressed on or after standard of care therapy and for which no standard of care therapy is available that would confer clinical benefit
Part 1 - Dose Escalation: Evaluable or measurable disease by RECISTv1.1
Part 2 - Dose Expansion: Measurable disease by RECISTv1.1
Adequate laboratory parameters as defined in protocol.
If residual treatment related toxicity from prior therapy: (a) Treatment related toxicity resolved to at least Grade 1 (alopecia excepted), or (b) Treatment related toxicity resolved to at least Grade 2 with prior approval of the Medical Monitor
Available archival or fresh tumor tissue (Formalin-fixed paraffin-embedded [FFPE])
Females: patient must be postmenopausal, surgically sterile, or agree to use adequate contraception (adequate as determined by the PI - may include abstinence) throughout the study and for a least 30 days following the last dose of PMD-026
Males: patient must be surgically sterile or must agree to use adequate contraception (adequate as determined by the PI - may include abstinence) throughout the study and for at least 30 days following the last dose of PMD-026
Males: patient must agree to refrain from donating sperm throughout the study and for at least 30 days following the last dose of PMD-026
Females: If of childbearing potential, the patient must have a negative serum pregnancy test
Less than or equal to 14 days from prior chemotherapy, biological or investigational therapy
Use of any medications known to result in a prolongation of the QT/QTc interval
Use of any medication that is a strong inducer or substrate of cytochrome P450 3A
Use of any medications that is a substrate of BCRP
Use of any medication that is a substrate of MATE2K
Less than or equal to 28 days from prior irradiation (including therapeutic radioisotopes such as strontium 89)
Less than or equal to 7 days from limited field irradiation for palliation
Less than or equal to 28 days from major surgical procedures
Less than or equal to 7 days from minor surgical procedures (no waiting period required following central catheter placement)
Central nervous system metastases, unless appropriately treated and neurologically stable for ≥ 28 days
Known history of leptomeningeal metastases
Uncontrolled bacterial, viral, or fungal infection (s) requiring systemic therapy
Pregnant or currently breast-feeding
Known Hepatitis B or Hepatitis C infection
Known HIV-positive with CD4+ cell counts > Known HIV-positive with a history of an AIDS-defining opportunistic infection
History of clinically significant cardiovascular abnormalities as outlined in protocol.
Presence of active gastrointestinal disease or other condition that is expected to interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea Grade ≥ 2, and malabsorption syndrome)
Inadequately controlled hypertension defined as systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg (patients with values above these levels must have their blood pressure controlled prior to starting treatment)
Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment
Other known active cancer(s) likely to require treatment in the next year that would impact the assessment of any study endpoints
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
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