Clinical trial Recruiting at 3 sites Phase 1 Interventional Ages 21 and up

Oral MBQ-167 treatment for advanced breast cancer

Official title: A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer

Run by MBQ Pharma · NCT06075810 · Data updated 2026-11-12

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.

More Breast Cancer trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages21 Years and up
SexAll
Enrollment48 (estimated)
SponsorMBQ Pharma
Industry-sponsored
Locations4 sites (Beverly Hills, California and 3 other locations)
StatusRecruiting
StartedNovember 9, 2023
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedAugust 31, 2026
Trial IDNCT06075810 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients who cannot take oral medications or have uncontrolled gastrointestinal conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While this approach is novel, similar studies targeting advanced breast cancer have shown promise in exploring new treatment options.

Who can join: the full rules

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 it's running

  • 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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.