Description:
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.
Title
- Brief Title: A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer
- Official Title: A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects
Clinical Trial IDs
- ORG STUDY ID:
GMI-1359-210
- NCT ID:
NCT04197999
Conditions
- HR+ Metastatic Breast Cancer
- Breast Cancer
- Breast Cancer Metastatic
Interventions
| Drug | Synonyms | Arms |
|---|
| GMI-1359 | | Single Ascending Dose followed by Multiple Doses |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Single Ascending Dose followed by Multiple Doses | Experimental | Up to 3 single ascending doses of GMI-1359 followed by the highest tolerated dose given for 3 consecutive days. | |
Eligibility Criteria
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | 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) |
| Time Frame: | Up to 4 months |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Area under the plasma concentration-time curve [AUC0-t and AUC0-∞] of GMI-1359 |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Maximum plasma concentration [Cmax] of GMI-1359 |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Time to reach maximum plasma concentration [tmax] of GMI-1359 |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Individual estimate of the terminal elimination rate constant [Λz] of GMI-1359 |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Half-life [t1/2] of GMI-1359 |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Total plasma clearance [CL] of GMI-1359 |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Apparent volume of distribution estimated at the terminal phase [Vz] of GMI-1359 |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Pre- and post-dose circulating tumor cells (CTC) enumeration to determine tumor cell mobilization [digital pathology assay] |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Pre-and post-dose CD34+ cell quantification to determine mobilization into peripheral blood [standard flow cytometry] |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | GlycoMimetics Incorporated |
Trial Keywords
- GMI-1359
- breast cancer
- HR+ metastatic breast cancer
Last Updated
April 1, 2021
