A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer
MBQ Pharma
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.
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 process the drug? * Does the drug slow, stop or eliminate cancer in human participants? Participants will be asked to: * provide informed consent * be evaluated by physicians and provide laboratory specimens to determine if eligible * take MBQ-167 orally twice a day for at least 21 days * may continue dosing, if safe to do so, until not effective or other decision to stop is made * participate in m…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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: *…
Interventions
- DrugMBQ-167
MBQ-167, an inhibitor of Rho GTPases Rac and Cdc42
Locations (4)
- Precision Next Gen Oncology & Research CenterBeverly Hills, California
- Florida Cancer Specialists / Sarah Cannon Research Institute / SCRISarasota, Florida
- Sarah Cannon Research Institute/SCRINashville, Tennessee
- FDI Clinical ResearchSan Juan