A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer

NCT06075810 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: MBQ-ABC001CDMRP-BC220292
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 4

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

Keywords

Advanced Breast Cancer; Metastatic Breast Cancer; Recurrent Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  To find the maximum tolerated dose (MTD) of MBQ-167 as a single agent administered orally, BID continuously for 21 days in participants with Advanced Breast Cancer (ABC) by evaluating for the presence or absence of dose-limiting toxicity (DLT) related to MBQ-167 administered in cohorts of participants at escalating sequential cohort dose levels.

  21 days

Secondary Outcomes (6)

• MBQ-167 PK parameter (Cmax/min)

  56 days

• MBQ-167 PK parameter (tmax)

  56 days

• MBQ-167 PK parameter (t1/2)

  56 days

• MBQ-167 PK parameter (AUC (0-t,0-24,∞))

  56 days

• MBQ-167 PD parameter (differential gene expression)

  16 days

Study Arms (1)

MBQ-167 oral capsule

EXPERIMENTAL

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

Drug: MBQ-167

Interventions

MBQ-167 DRUG

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

Also known as: Rac and Cdc42 inhibitor, Rac inhibitor, Cdc42 inhibitor, PAK inhibitor, Rac/Cdc42 inhibitor

MBQ-167 oral capsule

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MBQ Pharma: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (4)

Precision Next Gen Oncology & Research Center

Beverly Hills, California, 90212, United States

RECRUITING

Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI

Sarasota, Florida, 34232, United States

RECRUITING

Sarah Cannon Research Institute/SCRI

Nashville, Tennessee, 37203, United States

RECRUITING

FDI Clinical Research

San Juan, 00927, Puerto Rico

RECRUITING

Related Publications (6)

• 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.

  PMID: 34607932 BACKGROUND

• 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.

  PMID: 36861094 BACKGROUND

• 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.

  PMID: 28450422 BACKGROUND

• 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.

  PMID: 37397366 BACKGROUND

• 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.

  PMID: 29858187 BACKGROUND

• 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.

  PMID: 34074257 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Proto-Oncogene Proteins c-raf; PAK inhibitor MRIA9

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

raf Kinases; MAP Kinase Kinase Kinases; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Proto-Oncogene Proteins; Oncogene Proteins; Neoplasm Proteins

Study Officials

• Neil Sankar, MD

  CMO, MBQ Pharma

  STUDY DIRECTOR

Central Study Contacts

Scott Houston

CONTACT

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

Jose Rodriguez-Orengo, PhD

CONTACT

jose.rodriguez@mbqpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label dose escalation following a standard 3+3 cohort design with a 21 day Dose Limiting Toxicity (DLT) evaluation

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 10, 2023
• Study Start: November 9, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 31, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (3)