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

GlycoMimetics

Status and phase

Terminated

Phase 1

Conditions

Breast Cancer

HR+ Metastatic Breast Cancer

Breast Cancer Metastatic

Treatments

Drug: GMI-1359

Study type

Interventional

Funder types

Industry

Identifiers

NCT04197999

GMI-1359-210

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.