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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2020

Interventions

  • Drug: GMI-1359
    • Injection 10 mg/mL

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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)
    • Time Frame: Up to 4 months

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlycoMimetics Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paul K Marcom, MD, Principal Investigator, Duke University
    • Dorothy A Sipkins, MD, PhD, Principal Investigator, Duke University
  • Overall Contact(s)
    • GlycoMimetics, Inc., 240-243-1201, clinicaltrials@glycomimetics.com

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