Overview

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

Status:
Recruiting
Trial end date:
2024-10-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MBQ Pharma
Collaborator:
Congressionally Directed Medical Research Programs
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.

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 30 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 30 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.