Status:
RECRUITING
A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer
Lead Sponsor:
MBQ Pharma
Collaborating Sponsors:
Congressionally Directed Medical Research Programs
Conditions:
Breast Cancer
Breast Neoplasm
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief 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.
Detailed Description
The main questions this clinical trial aims to answer are: * What, if any, are the side effects of different dose levels in humans? * What is the maximum tolerated dose? * How does the human body pro...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06075810
Start Date
November 9 2023
End Date
October 31 2025
Last Update
December 12 2024
Active Locations (4)
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1
Precision Next Gen Oncology & Research Center
Beverly Hills, California, United States, 90212
2
Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI
Sarasota, Florida, United States, 34232
3
Sarah Cannon Research Institute/SCRI
Nashville, Tennessee, United States, 37203
4
FDI Clinical Research
San Juan, Puerto Rico, 00927