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

MBQ Pharma

Status and phase

Enrolling

Phase 1

Conditions

Breast Cancer Stage IV

Breast Cancer

Breast Neoplasm

Treatments

Drug: MBQ-167

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT06075810

MBQ-ABC001

CDMRP-BC220292 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment

48 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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.