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

A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Breast Cancer Metastatic; HR+ Metastatic Breast Cancer
• Intervention / Treatment: Drug: GMI-1359

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Ascending Dose followed by Multiple Doses; Up to 3 single ascending doses of GMI-1359 followed by the highest tolerated dose given for 3 consecutive days.	Drug: GMI-1359; Injection 10 mg/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	Up to 4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time curve [AUC0-t and AUC0-∞] of GMI-1359	Up to 16 weeks
Maximum plasma concentration [Cmax] of GMI-1359	Up to 16 weeks
Time to reach maximum plasma concentration [tmax] of GMI-1359	Up to 16 weeks
Individual estimate of the terminal elimination rate constant [Λz] of GMI-1359	Up to 16 weeks
Half-life [t1/2] of GMI-1359	Up to 16 weeks
Total plasma clearance [CL] of GMI-1359	Up to 16 weeks
Apparent volume of distribution estimated at the terminal phase [Vz] of GMI-1359	Up to 16 weeks
Pre- and post-dose circulating tumor cells (CTC) enumeration to determine tumor cell mobilization [digital pathology assay]	Up to 16 weeks
Pre-and post-dose CD34+ cell quantification to determine mobilization into peripheral blood [standard flow cytometry]	Up to 16 weeks

Collaborators and Investigators

• Sponsor: GlycoMimetics Incorporated
• Investigators: Principal Investigator: Jeremy Force, DO, Duke University; Principal Investigator: Dorothy A Sipkins, MD, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2019
• Primary Completion (Actual): August 25, 2021
• Study Completion (Actual): August 25, 2021

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: breast cancer; GMI-1359; HR+ metastatic breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: GMI-1359-210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No