A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer

Last updated: December 9, 2024
Sponsor: MBQ Pharma
Overall Status: Active - Recruiting

Phase

1

Condition

Breast Cancer

Cancer

Treatment

MBQ-167

Clinical Study ID

NCT06075810
MBQ-ABC001
CDMRP-BC220292
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • The investigator will evaluate these and other criteria to determine whether aparticipant can be included in this study.

  • Histologically and/or cytologically confirmed advanced breast cancer which hasprogressed after treatment with approved therapies or for which there are nostandard therapies available.

  • Participants with known brain metastases may be eligible if specific conditions aremet.

  • Life expectancy ≥6 months, in the opinion of the investigator, after startingMBQ-167.

  • Are able to swallow capsules twice daily with a meal.

Exclusion

Key Exclusion Criteria:

  • The investigator will evaluate these and other criteria to determine whether aparticipant should be excluded from this study.

  • Inability to take oral medication, or malabsorption syndrome or any otheruncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) thatmight impair the bioavailability of MBQ-167.

  • Females who are pregnant or breastfeeding.

  • Participants who have received any anticancer treatment within 4 weeks or anyinvestigational agent within 28 days prior to the first dose of trial drug or whohave not recovered from any acute toxicity greater than Grade 0 or 1 related toprevious anticancer treatment.

  • Participants who have received any anticancer treatment within 4 weeks or anyinvestigational agent within 28 days prior to the first dose of trial drug or whohave not recovered from any acute toxicity greater than Grade 0 or 1 related toprevious anticancer treatment.

  • Active malignancies other than advanced breast cancer will be excluded from thestudy.

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: MBQ-167
Phase: 1
Study Start date:
November 09, 2023
Estimated Completion Date:
October 31, 2025

Study 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

Connect with a study center

  • FDI Clinical Research

    San Juan, 00927
    Puerto Rico

    Active - Recruiting

  • Precision Next Gen Oncology & Research Center

    Beverly Hills, California 90212
    United States

    Active - Recruiting

  • Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute/SCRI

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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