MBQ-167 for Breast Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: MBQ Pharma

Disqualifiers: Pregnancy, Breastfeeding, Active malignancies, others

No Placebo Group

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.

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.

+3 more

Trial 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

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: MBQ-167 oral capsuleExperimental Treatment1 Intervention

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