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

Phase 1

Terminated

• Conditions: HR+ Metastatic Breast Cancer; Breast Cancer Metastatic; Breast Cancer
• Interventions: Drug: GMI-1359

• Registration Number: NCT04197999
• Lead Sponsor: GlycoMimetics Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-21
• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Primary Completion: 2021-08-25
• Study Completion: 2021-08-25
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose followed by Multiple Doses	GMI-1359	Up to 3 single ascending doses of GMI-1359 followed by the highest tolerated dose given for 3 consecutive days.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Total plasma clearance [CL] of GMI-1359	Up to 16 weeks
Maximum plasma concentration [Cmax] of GMI-1359	Up to 16 weeks
Individual estimate of the terminal elimination rate constant [Λz] of GMI-1359	Up to 16 weeks
Area under the plasma concentration-time curve [AUC0-t and AUC0-∞] of GMI-1359	Up to 16 weeks
Time to reach maximum plasma concentration [tmax] of GMI-1359	Up to 16 weeks
Half-life [t1/2] 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 CD34+ cell quantification to determine mobilization into peripheral blood [standard flow cytometry]	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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States