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NCT06075810 | RECRUITING | Breast Cancer

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

MBQ Pharma

Brief 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.

Condition or disease

Breast Cancer

Breast Neoplasm

Breast Cancer Stage IV

Intervention/treatment

MBQ-167

Phase

PHASE1

Detailed 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

Study Type : INTERVENTIONAL
Estimated Enrollment : 48 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer
Actual Study Start Date : 2023-11-09
Estimated Primary Completion Date : 2025-10-01
Estimated Study Completion Date : 2025-10-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer

Location Details

NCT06075810

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Precision Next Gen Oncology & Research Center

Beverly Hills, California, United States, 90212

RECRUITING

United States, Florida

Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI

Sarasota, florida, United States, 34232

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute/SCRI

Nashville, Tennessee, United States, 37203

RECRUITING

Puerto Rico,

FDI Clinical Research

Saint John, Puerto Rico, 00927