About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • MBQ-167

Treatment groups

48 Participants
are divided into 1 treatment group

Locations

4
Puerto Rico
FDI Clinical Research00927, San Juan Puerto Rico
United States
Precision Next Gen Oncology & Research Center90212, Beverly HillsCalifornia, United States
Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI34232, SarasotaFlorida, United States
Sarah Cannon Research Institute/SCRI37203, NashvilleTennessee, United States

Sponsors and collaborators

MBQ Pharma

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator