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 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 p

Trial Details

NCT ID
NCT05455619
Phase
PHASE1 / PHASE2
Sponsor
SynDevRx, Inc.
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Evexomostat
Locations (sample)
  • Loma Linda, California, United States|34.04835,-117.26115
  • Newport, California, United States|39.57738,-123.77474
  • San Diego, California, United States|32.71571,-117.16472
  • Miami, Florida, United States|25.77427,-80.19366
  • Hinsdale, Illinois, United States|41.80086,-87.93701

Key Eligibility Criteria

  • Patient is an adult male or postmenopausal female ≥18 years old at the time of informed consent(s) and has signed informed consent(s) before any tr…
  • Patient with histologically and/or cytologically confirmed diagnosis of HR+, HER2- breast cancer, as determined by the local laboratory.
  • Patient has identified PI3K pathway alteration, defined as a PIK3CA mutation or PTEN loss or an AKT1 mutation using a Food and Drug Administration …
  • Patient has locally advanced (not amenable to curative therapy or metastatic) breast cancer meeting any of the following categories:

For full eligibility, visit ClinicalTrials.gov.

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