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

Primary Purpose

HR+ Metastatic Breast Cancer, Breast Cancer, Breast Cancer Metastatic

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GMI-1359
Sponsored by
GlycoMimetics Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HR+ Metastatic Breast Cancer focused on measuring GMI-1359, breast cancer, HR+ metastatic breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Ascending Dose followed by Multiple Doses

Arm Description

Up to 3 single ascending doses of GMI-1359 followed by the highest tolerated dose given for 3 consecutive days.

Outcomes

Primary Outcome 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)

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2019
Last Updated
March 7, 2022
Sponsor
GlycoMimetics Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT04197999
Brief Title
A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer
Official Title
A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
After demonstrating the on target effect of GMI-1359 via pharmacodynamic markers (CXCR4 and E-selectin), Sponsor terminated the trial due to COVID-related slow enrollment.
Study Start Date
November 21, 2019 (Actual)
Primary Completion Date
August 25, 2021 (Actual)
Study Completion Date
August 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlycoMimetics Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HR+ Metastatic Breast Cancer, Breast Cancer, Breast Cancer Metastatic
Keywords
GMI-1359, breast cancer, HR+ metastatic breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Ascending Dose followed by Multiple Doses
Arm Type
Experimental
Arm Description
Up to 3 single ascending doses of GMI-1359 followed by the highest tolerated dose given for 3 consecutive days.
Intervention Type
Drug
Intervention Name(s)
GMI-1359
Intervention Description
Injection 10 mg/mL
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Area under the plasma concentration-time curve [AUC0-t and AUC0-∞] of GMI-1359
Time Frame
Up to 16 weeks
Title
Maximum plasma concentration [Cmax] of GMI-1359
Time Frame
Up to 16 weeks
Title
Time to reach maximum plasma concentration [tmax] of GMI-1359
Time Frame
Up to 16 weeks
Title
Individual estimate of the terminal elimination rate constant [Λz] of GMI-1359
Time Frame
Up to 16 weeks
Title
Half-life [t1/2] of GMI-1359
Time Frame
Up to 16 weeks
Title
Total plasma clearance [CL] of GMI-1359
Time Frame
Up to 16 weeks
Title
Apparent volume of distribution estimated at the terminal phase [Vz] of GMI-1359
Time Frame
Up to 16 weeks
Title
Pre- and post-dose circulating tumor cells (CTC) enumeration to determine tumor cell mobilization [digital pathology assay]
Time Frame
Up to 16 weeks
Title
Pre-and post-dose CD34+ cell quantification to determine mobilization into peripheral blood [standard flow cytometry]
Time Frame
Up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Force, DO
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dorothy A Sipkins, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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