Recruiting
Phase 1

MBQ-167

Sponsor:

MBQ Pharma

Code:

NCT06075810

Conditions

Breast Cancer

Breast Neoplasm

Breast Cancer Stage IV

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

MBQ-167

Study Details

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.

Conditions

Breast Cancer

Breast Neoplasm

Breast Cancer Stage IV

Study ID

NCT06075810

Start date

Nov 9, 2023

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

48 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MBQ-167 oral capsule

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

Interventions

MBQ-167

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

Primary outcome measure

  • Maximum Tolerated Dose (MTD) [ Time Frame: 21 days ]

Central Contacts and Locations

Central contacts

Scott Houston

(415) 404 8838scott.houston@mbqpharma.com

Jose Rodriguez-Orengo, PhD

jose.rodriguez@mbqpharma.com

Locations

Precision Next Gen Oncology & Research Center

Recruiting

Beverly Hills, California, United States, 90212

Contacts

Rebecca Godin

424-777-0708RebeccaG@NextGenOnc.com

Francisco Capilla

424-777-0708FranciscoC@NextGenOnc.com

Principal Investigator:

Kumar Sankhala, MD

Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Judy S Wang, MD

941-377-9993jswang@flcancer.com

Principal Investigator:

Judy S Wang, MD

Sarah Cannon Research Institute/SCRI

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Melissa Sindler

844-482-4812scri.ddureferrals@scri.com

Principal Investigator:

Denise Yardley, MD

More Information

Sponsor

MBQ Pharma

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Advanced Breast Cancer
  • Metastatic Breast Cancer
  • Recurrent Breast Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MBQ Pharma on 2026-08-31.