A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer
Purpose
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.
Conditions
- Breast Cancer
- Breast Neoplasm
- Breast Cancer Stage IV
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Open-label dose escalation following a standard 3+3 cohort design with a 21 day Dose Limiting Toxicity (DLT) evaluation
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental MBQ-167 oral capsule |
A dose ranging from 10mg to 400mg BID following a standard 3+3 cohort design |
|
Recruiting Locations
Beverly Hills, California 90212
Sarasota, Florida 34232
Nashville, Tennessee 37203
San Juan, Puerto Rico 00927
More Details
- Status
- Recruiting
- Sponsor
- MBQ Pharma
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 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 multiple visits that include additional evaluations, laboratory tests and diary review until after stopping the investigational drug