Oral MBQ-167 treatment for advanced breast cancer
A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer
This study is testing a new oral medication called MBQ-167 to see if it can help people with advanced breast cancer who haven't had success with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | MBQ Pharma Industry-sponsored |
| Locations | 4 sites (Beverly Hills, California and 3 other locations) |
| Trial ID | NCT06075810 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial evaluates the safety and effectiveness of MBQ-167, an oral medication, in patients with advanced breast cancer who have not responded to standard treatments. The study involves a dose-escalation approach to determine the maximum tolerated dose and assess side effects. Participants will take the medication twice daily for at least 21 days and undergo regular evaluations and laboratory tests to monitor their health and the drug's impact on cancer progression.
Who should consider this trial
Good fit: Ideal candidates are individuals with histologically confirmed advanced breast cancer that has progressed after standard therapies or for whom no standard therapies are available.
Not a fit: Patients who cannot take oral medications or have uncontrolled gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with advanced breast cancer who have limited alternatives.
How similar studies have performed: While this approach is novel, similar studies targeting advanced breast cancer have shown promise in exploring new treatment options.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Beverly Hills, California and 3 other locations
- 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 (Recruiting)
Study contacts
- Study coordinator: Scott Houston
- Email: scott.houston@mbqpharma.com
- Phone: (415) 404 8838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.