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

Description

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.

Conditions

Breast Cancer, Breast Neoplasm, Breast Cancer Stage IV

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Beverly Hills

Precision Next Gen Oncology & Research Center, Beverly Hills, California, United States, 90212

Sarasota

Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI, Sarasota, Florida, United States, 34232

Nashville

Sarah Cannon Research Institute/SCRI, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MBQ Pharma,

Neil Sankar, MD, STUDY_DIRECTOR, CMO, MBQ Pharma

Study Record Dates

2025-10-31