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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MBQ-167 for individuals with advanced breast cancer. Researchers aim to assess the safety and effectiveness of MBQ-167, particularly for those whose previous treatments were ineffective or intolerable. Participants will take MBQ-167 in capsule form twice daily. This trial may suit those with advanced breast cancer that has progressed after standard treatments, who can swallow capsules, and have a life expectancy of at least six months. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that MBQ-167 is likely to be safe for humans?

Research has shown that MBQ-167 has shown promise in studies with mice, where it helped stop breast cancer tumors from growing and spreading. These studies found the treatment to be minimally harmful to the mice, indicating potential safety for humans. However, this information comes from animal studies. As this trial is in an early phase, researchers are still assessing the safety of MBQ-167 for humans. Human safety might differ, so this trial serves as the first step to learn more. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

MBQ-167 is unique because it targets breast cancer in a novel way. Unlike standard treatments that often focus on hormone receptors or HER2 proteins, MBQ-167 works by inhibiting Rac and Cdc42, which are proteins involved in cancer cell movement and spread. This new mechanism of action could potentially slow down or prevent metastasis more effectively. Researchers are excited about MBQ-167 because it offers a fresh approach that might complement or even improve outcomes compared to traditional therapies such as chemotherapy or hormone therapy.

What evidence suggests that MBQ-167 might be an effective treatment for breast cancer?

Research has shown that MBQ-167, administered as an oral capsule in this trial, holds promise for treating breast cancer by targeting specific proteins that promote cancer cell growth and spread. In studies with mice, MBQ-167 shrank tumors and prevented cancer from spreading to other parts of the body, such as the lungs. This treatment proved effective against various types of breast cancer, including HER2-positive and triple-negative breast cancer. These findings suggest that MBQ-167 could be a viable option for patients with breast cancer, particularly when standard treatments have failed. ^{2 5 6 7 8}

Who Is on the Research Team?

Neil Sankar, MD

Principal Investigator

CMO, MBQ Pharma

Are You a Good Fit for This Trial?

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

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.

I may have brain metastases but meet certain conditions for treatment.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8643341/

Efficacy of Rac and Cdc42 inhibitor MBQ-167 in triple negative ... Accordingly, MBQ-167 inhibits mammary tumor growth, metastasis and angiogenesis in a HER2 type mouse model (12). Moreover, MBQ-167 has a bioavailability of ~35% ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S193652332400055X

Efficacy and delivery strategies of the dual Rac/Cdc42 ... The results presented herein demonstrate that free and liposomal MBQ-167 reduces cell viability, inhibit tumor growth, and decreases metastasis to lungs and ...

3. aacrjournals.org aacrjournals.org/mct/article/doi/10.1158/1535-7163.MCT-21-0348/673427/am/Efficacy-of-Rac-and-Cdc42-inhibitor-MBQ-167-in

Efficacy of Rac and Cdc42 inhibitor MBQ-167 in triple negative ... MBQ-167 inhibits tumor growth, and spontaneous and experimental metastasis in immunocompromised (human TNBC) and immunocompetent (mouse TNBC) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9970268/

Characterization of Novel Derivatives of MBQ-167, an Inhibitor ... We previously reported on the efficacy of MBQ-167, which blocks both Rac1 and Cdc42 in breast cancer cells and mouse models of metastasis. To identify compounds ...

5. aacrjournals.org aacrjournals.org/cancerres/article/82/12_Supplement/347/703516/Abstract-347-Comparative-activity-of-MBQ-167

Abstract 347: Comparative activity of MBQ-167 metabolites in ... MBQ-167 inhibits tumor growth and metastasis in experimental and spontaneous HER-positive and Triple negative breast cancer (TNBC) mouse models.

6. caymanchem.com caymanchem.com/product/35437/mbq-167?srsltid=AfmBOoq-gOqg5bCBerI2bVBE4y1gd9vUn6twVZePJn70mZ53bDyoRaDj

MBQ-167 (CAS Number: 2097938-73-1) It reduces Rac and Cdc42 GTP binding and GTPase activity and limits migration and mammosphere formation in MDA-MB-231 breast cancer cells when used at a ...

7. mbqpharma.com mbqpharma.com/science/

Science MBQ-167 is a first-in-class, selective GTPase inhibitor which has been shown to prevent metastasis and remove pre-existing metastases for breast cancer tumors.

8. aacrjournals.org aacrjournals.org/cancerrescommun/article/2/12/1711/712022/Characterization-of-Novel-Derivatives-of-MBQ-167

Characterization of Novel Derivatives of MBQ-167, an Inhibitor ... We previously reported on the efficacy of MBQ-167, which blocks both Rac1 and Cdc42 in breast cancer cells and mouse models of metastasis. To identify compounds ...