A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer
- Conditions
- Breast CancerBreast NeoplasmBreast Cancer Stage IV
- Interventions
- Registration Number
- NCT06075810
- Lead Sponsor
- MBQ Pharma
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- The investigator will evaluate these and other criteria to determine whether a participant can be included in this study.
- Histologically and/or cytologically confirmed advanced breast cancer which has progressed after treatment with approved therapies or for which there are no standard therapies available.
- Participants with known brain metastases may be eligible if specific conditions are met.
- Life expectancy ≥6 months, in the opinion of the investigator, after starting MBQ-167.
- Are able to swallow capsules twice daily with a meal.
Key
- The investigator will evaluate these and other criteria to determine whether a participant should be excluded from this study.
- Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of MBQ-167.
- Females who are pregnant or breastfeeding.
- Participants who have received any anticancer treatment within 4 weeks or any investigational agent within 28 days prior to the first dose of trial drug or who have not recovered from any acute toxicity greater than Grade 0 or 1 related to previous anticancer treatment.
- Participants who have received any anticancer treatment within 4 weeks or any investigational agent within 28 days prior to the first dose of trial drug or who have not recovered from any acute toxicity greater than Grade 0 or 1 related to previous anticancer treatment.
- Active malignancies other than advanced breast cancer will be excluded from the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description MBQ-167 oral capsule MBQ-167 A dose ranging from 10mg to 400mg BID following a standard 3+3 cohort design
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) 21 days 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.
- Secondary Outcome Measures
Name Time Method MBQ-167 PK/PD parameter (minimum dose for therapeutic response) 56 days Correlate differential gene expression change, objective response and PK parameter Cmax/min to identify a minimum dose for therapeutic response
MBQ-167 PK parameter (Cmax/min) 56 days Maximum and minimum observed plasma concentration at steady state
MBQ-167 PK parameter (tmax) 56 days Time to maximum plasma concentration
MBQ-167 PK parameter (t1/2) 56 days Terminal elimination half-life
MBQ-167 PD parameter (differential gene expression) 16 days Observed quantitative measurement of gene expression change from baseline
MBQ-167 PK parameter (AUC (0-t,0-24,∞)) 56 days Area under the concentration-time curve over the dosing interval time from time 0
Trial Locations
- Locations (4)
Precision Next Gen Oncology & Research Center
🇺🇸Beverly Hills, California, United States
Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI
🇺🇸Sarasota, Florida, United States
Sarah Cannon Research Institute/SCRI
🇺🇸Nashville, Tennessee, United States
FDI Clinical Research
🇵🇷San Juan, Puerto Rico