A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer
Recruiting · NCT06075810 · Interventional (participants receive a specific treatment) · Lead sponsor: MBQ Pharma
View the official record on ClinicalTrials.gov →Interventions studied
MBQ-167
What this trial is about
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.
Who can take part
Age range
21 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where it is running
4 locations listed across 3 US states.
- 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