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

G

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

4 participants in 1 patient group

Single Ascending Dose followed by Multiple Doses
Experimental group
Description:
Up to 3 single ascending doses of GMI-1359 followed by the highest tolerated dose given for 3 consecutive days.
Treatment:
Drug: GMI-1359

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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