Overview

A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer

Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlycoMimetics Incorporated
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.