RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2023-11-09
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06075810

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The investigator will evaluate these and other criteria to determine whether a participant can be included in this study.
  2. * 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.
  3. * Participants with known brain metastases may be eligible if specific conditions are met.
  4. * Life expectancy ≥6 months, in the opinion of the investigator, after starting MBQ-167.
  5. * Are able to swallow capsules twice daily with a meal.
  1. * The investigator will evaluate these and other criteria to determine whether a participant should be excluded from this study.
  2. * 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.
  3. * Females who are pregnant or breastfeeding.
  4. * 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.
  5. * 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.
  6. * Active malignancies other than advanced breast cancer will be excluded from the study.

Contacts and Locations

Study Contact

Scott Houston
CONTACT
(415) 404 8838
scott.houston@mbqpharma.com
Jose Rodriguez-Orengo, PhD
CONTACT
jose.rodriguez@mbqpharma.com

Principal Investigator

Neil Sankar, MD
STUDY_DIRECTOR
CMO, MBQ Pharma

Study Locations (Sites)

Precision Next Gen Oncology & Research Center
Beverly Hills, California, 90212
United States
Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI
Sarasota, Florida, 34232
United States
Sarah Cannon Research Institute/SCRI
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: MBQ Pharma

  • Neil Sankar, MD, STUDY_DIRECTOR, CMO, MBQ Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-09
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2023-11-09
Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

  • Advanced Breast Cancer
  • Metastatic Breast Cancer
  • Recurrent Breast Cancer

Additional Relevant MeSH Terms

  • Breast Cancer
  • Breast Neoplasm
  • Breast Cancer Stage IV