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NCT05455619 · ClinicalTrials.gov registry record · Phase 1
Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer
A Phase 1 study of Metastatic Breast Cancer and HR+/HER2-negative Breast Cancer, sponsored by SynDevRx.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 10
- Study locations
NCT05455619 is a Phase 1 study of Metastatic Breast Cancer and HR+/HER2-negative Breast Cancer that is actively recruiting participants, run by SynDevRx. The registered enrollment target is 52 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (75% lower). The trial reports 10 study locations across 8 states.
The verdict
NCT05455619, a Phase 1 study of Metastatic Breast Cancer and HR+/HER2-negative Breast Cancer, is actively recruiting participants, sponsored by SynDevRx.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a Phase 1b/2, open-label, parallel-arms pilot study in men and post-menopausal women with hormone receptor positive (HR+), HER2- advanced or metastatic breast cancer with an alteration in the PI3K pathway, including a mutation of the PIK3CA gene, PTEN loss, or AKT1 mutation, designed to determine the safety of evexomostat (SDX-7320) plus standard of care treatment alpelisib (BYL-719) or capivasertib and fulvestrant (each combined, the 'triplet therapy'), to measure the severity and number of hyperglycemic events, and to assess clinical, anti-tumor benefit of the triplet therapy. The purpose of this study is: * to characterize the safety of the triplet drug combination consisting of either alpelisib or capivasertib (per the treating oncologist's choice) and fulvestrant plus evexomostat, * to test whether evexomostat, when given in combination with either alpelisib or capivasertib and fulvestrant will reduce the number and severity of hyperglycemic events and/or reduce the number or dose of anti-diabetic medications needed to control the hyperglycemia for metabolically normal patients and those deemed at risk for capivasertib and alpelisib-induced hyperglycemia (insulin resistance, as measured by HOMA-IR, baseline elevated HbA1c or well-controlled type 2 diabetes), and * to assess preliminary anti-tumor efficacy for each combination and changes in key biomarkers and quality of life in this patient population.
Conditions Studied
Interventions
- DRUG Evexomostat
Study Locations (10)
California
- Loma Linda University Cancer Center - Loma Linda
- Hoag Memorial Hospital Presbyterian - Newport
- SHARP Healthcare - San Diego
Florida
- Miami Cancer Institute at Baptist Health - Miami
Illinois
- Hope and Healing Cancer Services - Hinsdale
Michigan
- Trinity Health - Ypsilanti
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- Penn State Milton S Hershey Medical Center - Hershey
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- Doctors Hospital of Laredo - Laredo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2022-08-26 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05455619
The ClinicalTrials.gov registry entry for NCT05455619 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (75% lower). The listed sponsor is SynDevRx, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Evexomostat is the first listed.
NCT05455619 reports 10 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05455619 about?
NCT05455619 is a clinical study titled "Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer". This is a Phase 1b/2, open-label, parallel-arms pilot study in men and post-menopausal women with hormone receptor positive (HR+), HER2- advanced or metastatic breast cancer with an alteration in the PI3K pathway, including a mutation of the PIK3CA gene, PTEN loss, or AKT1 mutation, designed to dete...
What is the current status of trial NCT05455619?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2022-08-26. Estimated completion is 2026-09.
What conditions does trial NCT05455619 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, HR+/HER2-negative Breast Cancer.
What interventions are being tested in trial NCT05455619?
The interventions under investigation include: Evexomostat (DRUG).
Who is sponsoring clinical trial NCT05455619?
This trial is sponsored by SynDevRx, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05455619 being conducted?
This trial has 10 study locations across California, Florida, Illinois, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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