Efficacy of Rac and Cdc42 Inhibitor MBQ-167 in Triple-negative Breast Cancer.
Ailed Cruz-Collazo, Jean F Ruiz-Calderon, Hector Picon...
https://pubmed.ncbi.nlm.nih.gov/34607932Actively Recruiting
Phase 1
Age: 21Years +
All Genders
ID06075810
A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer
Led by MBQ Pharma · Updated on 2024-12-12
48
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
Sponsors
M
MBQ Pharma
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying MBQ-167, an oral drug being tested in a Phase 1 clinical trial for people with advanced breast cancer that has not responded to standard treatments or is not tolerable. The trial aims to find out the side effects of different doses, the maximum dose that can be safely given, how the body processes the drug, and whether the drug can slow, stop, or eliminate cancer. Participants will take MBQ-167 capsules by mouth twice a day for at least 21 days. The study uses a dose-escalation design where doses range from 10mg to 400mg twice daily to identify the highest safe dose. Participants who tolerate the drug and benefit from it may continue taking it until it is no longer effective or it is decided to stop. This is an open-label trial, meaning both researchers and participants know the treatment being given. During the study, participants will have multiple visits for physician evaluations, laboratory tests, and diary reviews. Researchers will monitor side effects, how the drug moves through the body, and gene expression changes. The main outcome measured is the maximum tolerated dose after 21 days. The study includes ongoing assessments to track safety and drug effects while participants are taking MBQ-167.
CONDITIONS
Brief Title
A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer
Who Can Participate
Age: 21Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically and/or cytologically confirmed advanced breast cancer that has progressed after approved therapies or has no standard therapies available
- Participants with known brain metastases may be eligible if specific conditions are met
- Life expectancy of at least 6 months as judged by the investigator
- Able to swallow capsules twice daily with a meal
- Investigator evaluation confirms participant meets other inclusion criteria
You will not qualify if you...
- Inability to take oral medication or uncontrolled gastrointestinal conditions that impair drug absorption
- Females who are pregnant or breastfeeding
- Received any anticancer treatment within 4 weeks or investigational agent within 28 days before first dose
- Not recovered from acute toxicity greater than Grade 0 or 1 related to previous anticancer treatment
- Presence of active malignancies other than advanced breast cancer
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - At least 21 days and may continue until not effective or decision to stop
Participants take MBQ-167 orally twice a day for at least 21 days and may continue dosing if safe and effective. This phase includes multiple visits for evaluations, laboratory tests, and diary reviews.
Multiple visits during treatment period
Follow-up
Duration - Up to approximately 56 days after treatment start
Participants continue with multiple evaluations and laboratory tests after stopping the investigational drug to monitor safety and effects.
Multiple follow-up visits after treatment ends
Trial Site Locations
Total: 4 locations
1
Precision Next Gen Oncology & Research Center
Beverly Hills, California, United States, 90212
Actively Recruiting
2
Florida Cancer Specialists / Sarah Cannon Research Institute / SCRI
Sarasota, Florida, United States, 34232
Actively Recruiting
3
Sarah Cannon Research Institute/SCRI
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
FDI Clinical Research
San Juan, Puerto Rico, 00927
Actively Recruiting
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Research Team
S
Scott Houston
J
Jose Rodriguez-Orengo, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Characterization of Novel Derivatives of MBQ-167, an inhibitor of the GTP-binding proteins Rac/Cdc42.
Julia I Medina, Ailed Cruz-Collazo, Maria Del Mar Maldonado...
https://pubmed.ncbi.nlm.nih.gov/36861094Characterization of a Dual Rac/Cdc42 Inhibitor MBQ-167 in Metastatic Cancer.
Tessa Humphries-Bickley, Linette Castillo-Pichardo, Eliud Hernandez-O'Farrill...
https://pubmed.ncbi.nlm.nih.gov/28450422Rac and Cdc42 inhibitors reduce macrophage function in breast cancer preclinical models.
Anamaris Torres-Sanchez, Michael Rivera-Robles, Linette Castillo-Pichardo...
https://pubmed.ncbi.nlm.nih.gov/37397366Targeting Rac and Cdc42 GTPases in Cancer.
María Del Mar Maldonado, Suranganie Dharmawardhane
https://pubmed.ncbi.nlm.nih.gov/29858187Rac inhibition as a novel therapeutic strategy for EGFR/HER2 targeted therapy resistant breast cancer.
Luis D Borrero-García, Maria Del Mar Maldonado, Julia Medina-Velázquez...
https://pubmed.ncbi.nlm.nih.gov/34074257