RecruitingPhase 1NCT06075810

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

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

Sponsor

MBQ Pharma

Enrollment

48 participants

Start Date

Nov 9, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Neoplasm Breast Cancer Stage IV

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.

Eligibility

Min Age: 21 Years

Inclusion Criteria5

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.

Exclusion Criteria6

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.