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A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer

RecruitingPhase 1

A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer

Who can join

Ages 21 and older · All sexes

Full eligibility criteria
Key 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.

About the study

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.

What is being tested

Sponsor: MBQ Pharma · Participants: 48 · Started: Nov 9, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06075810

Locations in the U.S.

CaliforniaPrecision Next Gen Oncology & Research Center, Beverly Hills
FloridaFlorida Cancer Specialists / Sarah Cannon Research Institute / SCRI, Sarasota
TennesseeSarah Cannon Research Institute/SCRI, Nashville

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.