Breast Cancer, Breast Cancer Metastatic, HR+ Metastatic Breast Cancer
Conditions
Keywords
GMI-1359, breast cancer, HR+ metastatic breast cancer
Brief summary
This trial is being conducted to investigate the safety, tolerability, pharmacokinetics (the effect the body has on the drug), and pharmacodynamics (the effect the drug has on the body) of GMI-1359 when given with standard-of-care treatment to subjects with HR+ metastatic breast cancer.
Interventions
DRUGGMI-1359
Injection 10 mg/mL
Sponsors
GlycoMimetics Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed HR+ metastatic breast cancer, currently stable or minimally progressive on current endocrine-based therapy. * Continuing on current endocrine-based therapy with an aromatase inhibitor, selective estrogen receptor degrader, or selective estrogen receptor modulator; and must be medically eligible to remain on this therapy during the treatment period.
Exclusion criteria
* Uncontrolled acute life-threatening bacterial, viral, or fungal infection. * Subjects who are pregnant or breastfeeding * Concurrent treatment with any cytotoxic chemotherapy agent or other targeted therapies including HER2 targeting therapies * Currently receiving, or less than 28 days since ending treatment on another investigational drug. * Clinically significant cardiovascular disease. * Abnormal liver function. * Any medical, psychiatric, or other condition which, in the opinion of the investigator, is likely to interfere with trial completion, assessments, or interpretation of trial results, or otherwise would make the subject an inappropriate subject for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrences of dose-limiting toxicities (DLT) including protocol-defined adverse events (AEs)/serious adverse events (SAEs), and/or laboratory abnormalities will be assessed in order to determine recommended phase II dose (Safety and Tolerability) | Up to 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration [Cmax] of GMI-1359 | Up to 16 weeks |
| Time to reach maximum plasma concentration [tmax] of GMI-1359 | Up to 16 weeks |
| Individual estimate of the terminal elimination rate constant [Λz] of GMI-1359 | Up to 16 weeks |
| Half-life [t1/2] of GMI-1359 | Up to 16 weeks |
| Area under the plasma concentration-time curve [AUC0-t and AUC0-∞] of GMI-1359 | Up to 16 weeks |
| Apparent volume of distribution estimated at the terminal phase [Vz] of GMI-1359 | Up to 16 weeks |
| Pre- and post-dose circulating tumor cells (CTC) enumeration to determine tumor cell mobilization [digital pathology assay] | Up to 16 weeks |
| Pre-and post-dose CD34+ cell quantification to determine mobilization into peripheral blood [standard flow cytometry] | Up to 16 weeks |
| Total plasma clearance [CL] of GMI-1359 | Up to 16 weeks |
Countries
United States
Outcome results
None listed