Breast CancerPhase 1NCT06075810
A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer
A Phase 1 study testing MBQ-167 in people with Breast Cancer and Breast Neoplasm, run by MBQ Pharma at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer, Breast Neoplasm, Breast Cancer Stage IV
- What is being tested?
- MBQ-167
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 9 Nov 2023to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Jose Rodriguez-Orengo, PhD contact
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Precision Next Gen Oncology & Research Center
Beverly Hills, California, 90212
Rebecca Godin, 424-777-0708, RebeccaG@NextGenOnc.com
Francisco Capilla, 424-777-0708, FranciscoC@NextGenOnc.com
- Recruiting
Sarah Cannon Research Institute/SCRI
Nashville, Tennessee, 37203
Melissa Sindler, 844-482-4812, scri.ddureferrals@scri.com
Denise Yardley, MD
- Recruiting
Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI
Sarasota, Florida, 34232
Judy S Wang, MD, 941-377-9993, jswang@flcancer.com
Judy S Wang, MD
About this study
Official title: A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer
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.
Read the detailed description
The main questions this clinical trial aims to answer are:
- 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
- Breast Cancer, Breast Neoplasm, Breast Cancer Stage IV
- Being tested
- MBQ-167
- Keywords
- Advanced Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBQ-167Drug
Also called Rac and Cdc42 inhibitor, Rac inhibitor, Cdc42 inhibitor, PAK inhibitor
MBQ-167, an inhibitor of Rho GTPases Rac and Cdc42
| Study group | Role | What they receive |
|---|---|---|
| MBQ-167 oral capsule | Experimental | A dose ranging from 10mg to 400mg BID following a standard 3+3 cohort design Receives: Drug: MBQ-167 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days
Secondary outcomes (6)
MBQ-167 PK parameter (Cmax/min)
Maximum and minimum observed plasma concentration at steady state
Measured: 56 days
MBQ-167 PK parameter (tmax)
Time to maximum plasma concentration
Measured: 56 days
MBQ-167 PK parameter (t1/2)
Terminal elimination half-life
Measured: 56 days
MBQ-167 PK parameter (AUC (0-t,0-24,∞))
Area under the concentration-time curve over the dosing interval time from time 0
Measured: 56 days
MBQ-167 PD parameter (differential gene expression)
Observed quantitative measurement of gene expression change from baseline
Measured: 16 days
MBQ-167 PK/PD parameter (minimum dose for therapeutic response)
Correlate differential gene expression change, objective response and PK parameter Cmax/min to identify a minimum dose for therapeutic response
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start9 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Open-label dose escalation following a standard 3+3 cohort design with a 21 day Dose Limiting Toxicity (DLT) evaluation
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MBQ Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Neil Sankar, MD, Study director, CMO, MBQ Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075810
- Sponsor's protocol ID
- MBQ-ABC001
- Other IDs
- CDMRP-BC220292
- Status last verified
- Aug 2026
- First submitted
- 26 Sep 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34607932Medina 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.
PubMed 36861094Humphries-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.
PubMed 28450422Torres-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.
PubMed 37397366Maldonado 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.
PubMed 29858187Borrero-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.
PubMed 34074257
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06075810
- Acronym / sponsor ID
- MBQ-ABC001
- Conditions
- Breast Cancer, Breast Neoplasm, Breast Cancer Stage IV
- Keywords
- Advanced Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- MBQ PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main questions this clinical trial aims to answer are:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label dose escalation following a standard 3+3 cohort design with a 21 day Dose Limiting Toxicity (DLT) evaluation
| Arm | Type | Receives |
|---|---|---|
| MBQ-167 oral capsule | Experimental | Drug: MBQ-167A dose ranging from 10mg to 400mg BID following a standard 3+3 cohort design |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBQ-167Also: Rac and Cdc42 inhibitor, Rac inhibitor, Cdc42 inhibitor, PAK inhibitorMBQ-167, an inhibitor of Rho GTPases Rac and Cdc42 | Drug | MBQ-167 oral capsule |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 21 days
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.
6 secondary outcomes
MBQ-167 PK parameter (Cmax/min)
Time frame: 56 days
MBQ-167 PK parameter (tmax)
Time frame: 56 days
MBQ-167 PK parameter (t1/2)
Time frame: 56 days
MBQ-167 PK parameter (AUC (0-t,0-24,∞))
Time frame: 56 days
MBQ-167 PD parameter (differential gene expression)
Time frame: 16 days
MBQ-167 PK/PD parameter (minimum dose for therapeutic response)
Time frame: 56 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 34607932Cruz-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.
- Background: PubMed 36861094Medina 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.
- Background: PubMed 28450422Humphries-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.
- Background: PubMed 37397366Torres-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.
- Background: PubMed 29858187Maldonado 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.
- Background: PubMed 34074257Borrero-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose Rodriguez-Orengo, PhD contact
Neil Sankar, MD study director
CMO, MBQ Pharma
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MBQ-167 in people with Breast Cancer and Breast Neoplasm, run by MBQ Pharma at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott Houston ((415) 404 8838, scott.houston@mbqpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06075810, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.