Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07604571
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced HR+/HER2- Breast Cancer

Eligibility Criteria

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

Interventions

  • IEV407 — DRUG
    Oral administration
  • Fulvestrant — DRUG
    Intramuscular injection. Approved medication.
  • Letrozole — DRUG
    Oral administration. Approved medication.

Study Details

The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-negative) breast cancer.

Key Dates

First listed
May 22, 2026
Start date
May 28, 2026
Status verified
Aug 2026
Primary completion
Jun 8, 2032
Completion
Jun 8, 2032

Study Design

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

Arms

  • Experimental: Dose escalation: IEV407 single agent
    IEV407 single agent
  • Experimental: Dose escalation: IEV407 + fulvestrant
    IEV407 in combination with fulvestrant
  • Experimental: Dose escalation: IEV407 + letrozole
    IEV407 in combination with letrozole
  • Experimental: Dose expansion, recommended dose (RD)-1: IEV407 + fulvestrant
    IEV407 in combination with fulvestrant
  • Experimental: Dose expansion, RD-2 (optional dose optimization): IEV407 + fulvestrant
    IEV407 in combination with fulvestrant

Primary Outcome Measure

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 (2)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06520
Jing Du (PRINCIPAL_INVESTIGATOR)
Mary Crowley Cancer ResearchDallasTexas75251
Pramitha Kondancheri
[email protected]
+1 972 566 3000
Reva Schneider (PRINCIPAL_INVESTIGATOR)

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