A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer
NCT ID: NCT06075810
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2023-11-09
2025-10-31
Brief Summary
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Detailed Description
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* What, if any, are the side effects of different dose levels in humans?
* What is the maximum tolerated dose?
* How does the human body process the drug?
* Does the drug slow, stop or eliminate cancer in human participants?
Participants will be asked to:
* provide informed consent
* be evaluated by physicians and provide laboratory specimens to determine if eligible
* take MBQ-167 orally twice a day for at least 21 days
* may continue dosing, if safe to do so, until not effective or other decision to stop is made
* participate in multiple visits that include additional evaluations, laboratory tests and diary review until after stopping the investigational drug
Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MBQ-167 oral capsule
A dose ranging from 10mg to 400mg BID following a standard 3+3 cohort design
MBQ-167
MBQ-167, an inhibitor of Rho GTPases Rac and Cdc42
Interventions
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MBQ-167
MBQ-167, an inhibitor of Rho GTPases Rac and Cdc42
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
21 Years
ALL
No
Sponsors
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Congressionally Directed Medical Research Programs
FED
MBQ Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Neil Sankar, MD
Role: STUDY_DIRECTOR
CMO, MBQ Pharma
Locations
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Precision Next Gen Oncology & Research Center
Beverly Hills, California, United States
Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI
Sarasota, Florida, United States
Sarah Cannon Research Institute/SCRI
Nashville, Tennessee, United States
FDI Clinical Research
San Juan, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Rebecca Godin
Role: primary
Francisco Capilla
Role: backup
Judy S Wang, MD
Role: primary
Melissa Sindler
Role: primary
Mirelis Acosta-Rivera, MD
Role: primary
Michelle Echeandia, MT, MSMT
Role: backup
References
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Cruz-Collazo A, Ruiz-Calderon JF, Picon H, Borrero-Garcia LD, Lopez I, Castillo-Pichardo L, Del Mar Maldonado M, Duconge J, Medina JI, Bayro MJ, Hernandez-O'Farrill E, Vlaar CP, Dharmawardhane S. Efficacy of Rac and Cdc42 Inhibitor MBQ-167 in Triple-negative Breast Cancer. Mol Cancer Ther. 2021 Dec;20(12):2420-2432. doi: 10.1158/1535-7163.MCT-21-0348. Epub 2021 Oct 4.
Medina JI, Cruz-Collazo A, Del Mar Maldonado M, Gascot TM, Borrero-Garcia LD, Cooke M, Kazanietz MG, O'Farril EH, Vlaar CP, Dharmawardhane S. Characterization of Novel Derivatives of MBQ-167, an inhibitor of the GTP-binding proteins Rac/Cdc42. Cancer Res Commun. 2022 Dec;2(12):1711-1726. doi: 10.1158/2767-9764.crc-22-0303. Epub 2022 Dec 29.
Humphries-Bickley T, Castillo-Pichardo L, Hernandez-O'Farrill E, Borrero-Garcia LD, Forestier-Roman I, Gerena Y, Blanco M, Rivera-Robles MJ, Rodriguez-Medina JR, Cubano LA, Vlaar CP, Dharmawardhane S. Characterization of a Dual Rac/Cdc42 Inhibitor MBQ-167 in Metastatic Cancer. Mol Cancer Ther. 2017 May;16(5):805-818. doi: 10.1158/1535-7163.MCT-16-0442.
Torres-Sanchez A, Rivera-Robles M, Castillo-Pichardo L, Martinez-Ferrer M, Dorta-Estremera SM, Dharmawardhane S. Rac and Cdc42 inhibitors reduce macrophage function in breast cancer preclinical models. Front Oncol. 2023 Jun 16;13:1152458. doi: 10.3389/fonc.2023.1152458. eCollection 2023.
Maldonado MDM, Dharmawardhane S. Targeting Rac and Cdc42 GTPases in Cancer. Cancer Res. 2018 Jun 15;78(12):3101-3111. doi: 10.1158/0008-5472.CAN-18-0619. Epub 2018 Jun 1.
Borrero-Garcia LD, Del Mar Maldonado M, Medina-Velazquez J, Troche-Torres AL, Velazquez L, Grafals-Ruiz N, Dharmawardhane S. Rac inhibition as a novel therapeutic strategy for EGFR/HER2 targeted therapy resistant breast cancer. BMC Cancer. 2021 Jun 1;21(1):652. doi: 10.1186/s12885-021-08366-7.
Other Identifiers
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CDMRP-BC220292
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MBQ-ABC001
Identifier Type: -
Identifier Source: org_study_id