Health Trials

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

ConditionsBreast CancerBreast NeoplasmBreast Cancer Stage IV
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorMBQ Pharma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MBQ-167

    Drug

    MBQ-167, an inhibitor of Rho GTPases Rac and Cdc42

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: MBQ-167 oral capsuleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose (MTD)

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.

Time frame
21 days

Secondary outcomes

1

MBQ-167 PK parameter (Cmax/min)

Maximum and minimum observed plasma concentration at steady state

Time frame
56 days
2

MBQ-167 PK parameter (tmax)

Time to maximum plasma concentration

Time frame
56 days
3

MBQ-167 PK parameter (t1/2)

Terminal elimination half-life

Time frame
56 days
4

MBQ-167 PK parameter (AUC (0-t,0-24,∞))

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

Time frame
56 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MBQ Pharma

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator

Source ClinicalTrials.gov
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