Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation. Phase II: Further characterize the safety and tolerability of GVV858 in combination with fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.

Trial Details

NCT ID
NCT07288359
Phase
PHASE1 / PHASE2
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • GVV858
  • Fulvestrant
  • Letrozole
Locations (sample)
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Odense C, Denmark|55.40841,10.39538
  • Essen, Germany|51.45657,7.01228
  • Milan, MI, Italy|42.78235,12.59836
  • Milan, Italy|42.78235,12.59836

Key Eligibility Criteria

  • Age ≥ 18 years old.
  • Patients with one of the following histologically or cytologically confirmed advanced cancers:
  • Phase I (patients with one of the following cancers, from whom no standard therapy is available or appropriate in the judgment of the investigator):
  • HR+/HER2- advanced breast cancer (aBC) with disease progression on or following at least one line of hormone-based therapy in combination with a CD…

For full eligibility, visit ClinicalTrials.gov.

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