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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07288359
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GVV858 — DRUG
    Experimental
  • Fulvestrant — DRUG
    Approved medication
  • Letrozole — DRUG
    Approved medication

Study Details

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.

Key Dates

Start date
Dec 29, 2025
Status verified
Jun 2026
Primary completion
May 9, 2031
Completion
May 9, 2031

Study Design

Enrollment
205 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: GVV858 Single Agent (Arm A)
    Phase I
  • Experimental: GVV858 in combination with fulvestrant (Arm B)
    Phase I
  • Experimental: GVV858 in combination with letrozole (Arm C)
    Phase I
  • Experimental: GVV858 in combination with fulvestrant (Arm D)
    Phase II, recommended dose regimen 1
  • Experimental: GVV858 in combination with fulvestrant (Arm E)
    Phase II, recommended dose regimen 2, optional dose optimization

Primary Outcome Measure

Phase I: Incidence and severity of dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (1)

FacilityCityStateZIPSite coordinators
Tennessee Oncology PLLCNashvilleTennessee37203
Jeffery Russell (PRINCIPAL_INVESTIGATOR)

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