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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests increasing doses of MBQ-167, a medicine taken by mouth. It is for people with advanced breast cancer whose standard treatment has stopped working or caused side effects they could not tolerate.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have advanced breast cancer confirmed by testing tissue or cells. The cancer must have grown after approved treatment, or no standard treatment is available.
  • People whose cancer has spread to the brain may join if they meet certain conditions.
  • The study doctor expects you to live at least 6 months after starting MBQ-167.
  • Can swallow capsules twice a day with a meal.
  • The study doctor will check these and other rules to decide if you can join.

Who can't join

  • Cannot take medicine by mouth, or have trouble absorbing it. Uncontrolled stomach or bowel problems, such as nausea, diarrhea, or vomiting, may also keep you from joining.
  • Are pregnant or breastfeeding.
  • Had cancer treatment within 4 weeks before the first study dose, or an experimental treatment within 28 days before it.
  • Still have side effects from earlier cancer treatment that are more than mild.
  • Have another active cancer besides advanced breast cancer.
  • The study doctor will check these and other rules that may keep you from joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (3)

CA

FL

TN