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Trial Title:
A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer
NCT ID:
NCT06075810
Condition:
Breast Cancer
Breast Neoplasm
Breast Cancer Stage IV
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Advanced Breast Cancer
Metastatic Breast Cancer
Recurrent Breast Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Open-label dose escalation following a standard 3+3 cohort design with a 21 day Dose
Limiting Toxicity (DLT) evaluation
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MBQ-167
Description:
MBQ-167, an inhibitor of Rho GTPases Rac and Cdc42
Arm group label:
MBQ-167 oral capsule
Other name:
Rac and Cdc42 inhibitor
Other name:
Rac inhibitor
Other name:
Cdc42 inhibitor
Other name:
PAK inhibitor
Other name:
Rac/Cdc42 inhibitor
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.
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
Criteria for eligibility:
Criteria:
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.
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 30 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 30 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.
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
FDI Clinical Research
Address:
City:
San Juan
Zip:
00927
Country:
Puerto Rico
Status:
Recruiting
Contact:
Last name:
Mirelis Acosta-Rivera, MD
Phone:
(787) 722-1248
Email:
info@fdipr.com
Contact backup:
Last name:
Michelle Echeandia, MT, MSMT
Phone:
(787) 722-1248
Email:
mecheandia@fdipr.com
Start date:
November 9, 2023
Completion date:
October 31, 2024
Lead sponsor:
Agency:
MBQ Pharma
Agency class:
Industry
Collaborator:
Agency:
Congressionally Directed Medical Research Programs
Agency class:
U.S. Fed
Source:
MBQ Pharma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06075810
