MBQ-167 for Breast Cancer

Recruiting at 3 trial locations

Overseen By Kumar Sankhala, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: MBQ Pharma

Disqualifiers: Pregnancy, Breastfeeding, Active malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

48 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial requires that participants stop any anticancer treatment at least 4 weeks before starting the trial drug. It does not specify about other medications, so you should discuss your current medications with the trial team.

Research Team

Neil Sankar, MD

Principal Investigator

CMO, MBQ Pharma

Eligibility Criteria

This trial is for adults with advanced breast cancer that has worsened after standard treatments or when no standard treatments are available. Participants must have a life expectancy of at least 6 months and be able to swallow capsules twice daily. Those with brain metastases may qualify if they meet certain conditions.

Inclusion Criteria

Key

The investigator will assess these and other qualifications to decide if a participant meets the requirements for this research.

My advanced breast cancer has worsened after standard treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants take MBQ-167 orally twice a day for at least 21 days

3 weeks

Multiple visits for evaluations and laboratory tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Multiple visits for evaluations and laboratory tests

Open-label extension

Participants may continue dosing if safe until not effective or other decision to stop is made

Treatment Details

Interventions

• MBQ-167

Trial Overview The study is testing MBQ-167, an oral medication, in people with advanced breast cancer. It's an early-phase trial (Phase 1) where the safety and best dose of MBQ-167 are being determined since usual treatments haven't worked or aren't suitable.

Participant Groups

Group I: MBQ-167 oral capsule Experimental Treatment 1 Intervention

A dose ranging from 10mg to 400mg BID following a standard 3+3 cohort design

Who Is Running the Clinical Trial?

MBQ Pharma

Lead Sponsor

Trials

1

Recruited

50+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+