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

Sponsor
MBQ Pharma (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06075810
Collaborator
United States Department of Defense (U.S. Fed)
48
Enrollment
1
Location
1
Arm
12.9
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
Open-label dose escalation following a standard 3+3 cohort design with a 21 day Dose Limiting Toxicity (DLT) evaluationOpen-label dose escalation following a standard 3+3 cohort design with a 21 day Dose Limiting Toxicity (DLT) evaluation
Masking:
None (Open Label)
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
Anticipated Study Start Date :
Oct 5, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose (MTD) [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.

    Secondary Outcome Measures

    1. MBQ-167 PK parameter (Cmax/min) [56 days]

      Maximum and minimum observed plasma concentration at steady state

    2. MBQ-167 PK parameter (tmax) [56 days]

      Time to maximum plasma concentration

    3. MBQ-167 PK parameter (t1/2) [56 days]

      Terminal elimination half-life

    4. MBQ-167 PK parameter (AUC (0-t,0-24,∞)) [56 days]

      Area under the concentration-time curve over the dosing interval time from time 0

    5. MBQ-167 PD parameter (differential gene expression) [16 days]

      Observed quantitative measurement of gene expression change from baseline

    6. MBQ-167 PK/PD parameter (minimum dose for therapeutic response) [56 days]

      Correlate differential gene expression change, objective response and PK parameter Cmax/min to identify a minimum dose for therapeutic response

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    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 30 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 30 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 FDI Clinical Research San Juan Puerto Rico 00927

    Sponsors and Collaborators

    • MBQ Pharma
    • United States Department of Defense

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    MBQ Pharma
    ClinicalTrials.gov Identifier:
    NCT06075810
    Other Study ID Numbers:
    • MBQ-ABC001
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by MBQ Pharma
    Advanced Breast Cancer
    Metastatic Breast Cancer
    Recurrent Breast Cancer
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Oct 10, 2023