Breast Cancer, Breast Cancer Stage IV, Breast Neoplasm
Conditions
Keywords
Advanced Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
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.
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
Interventions
DRUGMBQ-167
MBQ-167, an inhibitor of Rho GTPases Rac and Cdc42
Sponsors
MBQ Pharma
Congressionally Directed Medical Research Programs
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label dose escalation following a standard 3+3 cohort design with a 21 day Dose Limiting Toxicity (DLT) evaluation
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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 with a meal. 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MBQ-167 PK parameter (Cmax/min) | 56 days | Maximum and minimum observed plasma concentration at steady state |
| MBQ-167 PK parameter (tmax) | 56 days | Time to maximum plasma concentration |
| MBQ-167 PK parameter (t1/2) | 56 days | Terminal elimination half-life |
| MBQ-167 PK parameter (AUC (0-t,0-24,∞)) | 56 days | Area under the concentration-time curve over the dosing interval time from time 0 |
| MBQ-167 PD parameter (differential gene expression) | 16 days | Observed quantitative measurement of gene expression change from baseline |
| MBQ-167 PK/PD parameter (minimum dose for therapeutic response) | 56 days | Correlate differential gene expression change, objective response and PK parameter Cmax/min to identify a minimum dose for therapeutic response |
Countries
Puerto Rico, United States
Contacts
CONTACTScott Houston
CONTACTJose Rodriguez-Orengo, PhD
STUDY_DIRECTORNeil Sankar, MD
CMO, MBQ Pharma
Outcome results
None listed