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

RECRUITINGPhase 1Sponsored by MBQ Pharma
Actively Recruiting
PhasePhase 1
SponsorMBQ Pharma
Started2023-11-09
Est. completion2025-10-01
Eligibility
Age21 Years+
Healthy vol.Accepted
Locations3 sites

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

Age: 21 Years+Healthy volunteers accepted
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.

Conditions4

Breast CancerBreast Cancer Stage IVBreast NeoplasmCancer

Locations3 sites

California

1 site
Precision Next Gen Oncology & Research Center
Beverly Hills, California, 90212
Rebecca Godin424-777-0708RebeccaG@NextGenOnc.com

Florida

1 site
Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI
Sarasota, Florida, 34232
Judy S Wang, MD941-377-9993jswang@flcancer.com

Tennessee

1 site
Sarah Cannon Research Institute/SCRI
Nashville, Tennessee, 37203
Melissa Sindler844-482-4812scri.ddureferrals@scri.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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