A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer
| Registry | NCT06075810 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional; na, sequential, masking: none, treatment |
| Enrollment | 48 (Estimated) |
| Sponsor | MBQ Pharma (Industry); collaborators: Congressionally Directed Medical Research Programs |
| Conditions | Breast Cancer, Breast Neoplasm, Breast Cancer Stage IV |
| Interventions | MBQ-167 (Drug) |
| Dates | start 2023-11-09, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2023-10-10, last updated 2026-08-31 |
| Locations | 4 sites in United States, Puerto Rico |
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All trials for Breast Cancer All trials for Breast Neoplasm All trials of MBQ-167
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.
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| MBQ-167 oral capsule | Experimental | Drug: MBQ-167 | A dose ranging from 10mg to 400mg BID following a standard 3+3 cohort design |
Sex: All, ages: 21 Years to any
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: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Precision Next Gen Oncology & Research Center | Beverly Hills, California | United States | Recruiting |
| Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI | Sarasota, Florida | United States | Recruiting |
| Sarah Cannon Research Institute/SCRI | Nashville, Tennessee | United States | Recruiting |
| FDI Clinical Research | San Juan | Puerto Rico | Completed |