A Phase 1, open-label, dose-escalation clinical trial of MBQ-167 in participants with advanced Breast Cancer for whom Standard of Care (SOC) has failed or has proven intolerable.
The main questions this clinical trial aims to answer are: * What, if any, are the side effects of different dose levels in humans? * What is the maximum tolerated dose? * How does the human body process the drug? * Does the drug slow, stop or eliminate cancer in human participants? Participants will be asked to: * provide informed consent * be evaluated by physicians and provide laboratory specimens to determine if eligible * take MBQ-167 orally twice a day for at least 21 days * may continue dosing, if safe to do so, until not effective or other decision to stop is made * participate in multiple visits that include additional evaluations, laboratory tests and diary review until after stopping the investigational drug
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
MBQ-167, an inhibitor of Rho GTPases Rac and Cdc42
Precision Next Gen Oncology & Research Center
Beverly Hills, California, United States
RECRUITINGFlorida Cancer Specialists / Sarah Cannon Research Institute / SCRI
Sarasota, Florida, United States
RECRUITINGSarah Cannon Research Institute/SCRI
Nashville, Tennessee, United States
Maximum Tolerated Dose (MTD)
To find the maximum tolerated dose (MTD) of MBQ-167 as a single agent administered orally, BID continuously for 21 days in participants with Advanced Breast Cancer (ABC) by evaluating for the presence or absence of dose-limiting toxicity (DLT) related to MBQ-167 administered in cohorts of participants at escalating sequential cohort dose levels.
Time frame: 21 days
MBQ-167 PK parameter (Cmax/min)
Maximum and minimum observed plasma concentration at steady state
Time frame: 56 days
MBQ-167 PK parameter (tmax)
Time to maximum plasma concentration
Time frame: 56 days
MBQ-167 PK parameter (t1/2)
Terminal elimination half-life
Time frame: 56 days
MBQ-167 PK parameter (AUC (0-t,0-24,∞))
Area under the concentration-time curve over the dosing interval time from time 0
Time frame: 56 days
MBQ-167 PD parameter (differential gene expression)
Observed quantitative measurement of gene expression change from baseline
Time frame: 16 days
MBQ-167 PK/PD parameter (minimum dose for therapeutic response)
Correlate differential gene expression change, objective response and PK parameter Cmax/min to identify a minimum dose for therapeutic response
Time frame: 56 days
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FDI Clinical Research
San Juan, Puerto Rico
COMPLETED