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

December 9, 2024 updated by: MBQ Pharma

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • FDI Clinical Research
        • Principal Investigator:
          • Mirelis Acosta-Rivera, MD
        • Contact:
          • Mirelis Acosta-Rivera, MD
          • Phone Number: (787) 722-1248
          • Email: info@fdipr.com
        • Contact:
  • United States
    • California
      • Beverly Hills, California, United States, 90212
        • Recruiting
        • Precision Next Gen Oncology & Research Center
        • Principal Investigator:
          • Kumar Sankhala, MD
        • Contact:
        • Contact:
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI
        • Contact:
        • Principal Investigator:
          • Judy S Wang, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute/SCRI
        • Principal Investigator:
          • Denise Yardley, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBQ-167 oral capsule
A dose ranging from 10mg to 400mg BID following a standard 3+3 cohort design
Drug: MBQ-167
MBQ-167, an inhibitor of Rho GTPases Rac and Cdc42
Other Names:
  • Rac and Cdc42 inhibitor
  • Rac inhibitor
  • Cdc42 inhibitor
  • PAK inhibitor
  • Rac/Cdc42 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD)
Time Frame: 21 days
To find the maximum tolerated dose (MTD) of MBQ-167 as a single agent administered orally, BID continuously for 21 days in participants with Advanced Breast Cancer (ABC) by evaluating for the presence or absence of dose-limiting toxicity (DLT) related to MBQ-167 administered in cohorts of participants at escalating sequential cohort dose levels.
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MBQ-167 PK parameter (Cmax/min)
Time Frame: 56 days
Maximum and minimum observed plasma concentration at steady state
56 days
MBQ-167 PK parameter (tmax)
Time Frame: 56 days
Time to maximum plasma concentration
56 days
MBQ-167 PK parameter (t1/2)
Time Frame: 56 days
Terminal elimination half-life
56 days
MBQ-167 PK parameter (AUC (0-t,0-24,∞))
Time Frame: 56 days
Area under the concentration-time curve over the dosing interval time from time 0
56 days
MBQ-167 PD parameter (differential gene expression)
Time Frame: 16 days
Observed quantitative measurement of gene expression change from baseline
16 days
MBQ-167 PK/PD parameter (minimum dose for therapeutic response)
Time Frame: 56 days
Correlate differential gene expression change, objective response and PK parameter Cmax/min to identify a minimum dose for therapeutic response
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MBQ Pharma

Collaborators

Congressionally Directed Medical Research Programs

Investigators

  • Study Director: Neil Sankar, MD, CMO, MBQ Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

November 9, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBQ-ABC001
  • CDMRP-BC220292 (Other Grant/Funding Number: CDMRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on MBQ-167

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe