NCT04197999

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

Terminated Phase 1 Last updated 22 March 2022

What this trial tests

Phase 1 trial testing GMI-1359 in HR+ Metastatic Breast Cancer in 4 participants. Terminated before completion.

Timeline

21 November 2019

Primary endpoint
25 August 2021

25 August 2021

Quick facts

Lead sponsor	GlycoMimetics Incorporated
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	21 November 2019
Primary completion	25 August 2021
Estimated completion	25 August 2021
Sites	1 location across United States

Drugs / interventions tested

• GMI-1359 — full drug profile →

Conditions studied

• HR+ Metastatic Breast Cancer — all drugs for HR+ Metastatic Breast Cancer →
• Breast Cancer — all drugs for Breast Cancer →
• Breast Cancer Metastatic — all drugs for Breast Cancer Metastatic →

Sponsor

GlycoMimetics Incorporated — full company profile →

Who can join

18 and older, any sex, with HR+ Metastatic Breast Cancer or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Research trends in pharmacological modulation of tumor-associated macrophages.
   Wang N, Wang S, Wang X, Zheng Y, et al · · 2021 · cited 88× · PMID 33463063 · DOI 10.1002/ctm2.288
2. Glycomimetics for the inhibition and modulation of lectins.
   Leusmann S, Ménová P, Shanin E, Titz A, et al · · 2023 · cited 73× · PMID 37232696 · DOI 10.1039/d2cs00954d
3. Translating the Science of Cancer Dormancy to the Clinic.
   Aguirre-Ghiso JA. · · 2021 · cited 47× · PMID 34429327 · DOI 10.1158/0008-5472.can-21-1407
4. Clinical and Biological Aspects of Disseminated Tumor Cells and Dormancy in Breast Cancer.
   Ring A, Spataro M, Wicki A, Aceto N. · · 2022 · cited 22× · PMID 35837334 · DOI 10.3389/fcell.2022.929893
5. Abnormal Glycosylation of Cancer Stem Cells and Targeting Strategies.
   Khan T, Cabral H. · · 2021 · cited 20× · PMID 33889547 · DOI 10.3389/fonc.2021.649338
6. Targeting the chemokine receptor CXCR4 for cancer therapies.
   Rueda A, Serna N, Mangues R, Villaverde A, et al · · 2025 · cited 14× · PMID 40307933 · DOI 10.1186/s40364-025-00778-y
7. Hematopoietic Niche Hijacking in Bone Metastases: Roles of Megakaryocytes, Erythroid Lineage Cells, and Perivascular Stromal Subsets.
   Alkhatib AR, Elshimy Y, Atassi B, Mohammad KS. · · 2026 · PMID 41595694 · DOI 10.3390/biomedicines14010161