Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06726148
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced CCNE1-amplified Solid Tumors
  • Advanced HR+/HER2- Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • ECI830 — DRUG
    Experimental
  • ribociclib — DRUG
    Approved medication
  • fulvestrant — DRUG
    Approved medication

Study Details

Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies. Phase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.

Key Dates

Start date
Apr 3, 2025
Status verified
Apr 2026
Primary completion
Sep 25, 2028
Completion
Sep 25, 2028

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ECI830 Single Agent (Arm A)
    Phase I
  • Experimental: Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B)
    Phase I
  • Experimental: Ribociclib in combination with fulvestrant (Arm C)
    Phase II
  • Experimental: ECI830 in combination with fulvestrant (Arm D)
    Phase II
  • Experimental: ECI830 in combination with ribociclib and fulvestrant (Arm E)
    Phase II
  • Experimental: ECI830 in combination with ribociclib and fulvestrant (Arm F)
    Phase II

Primary Outcome Measure

Phase I: Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 2 years ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of California LALos AngelesCalifornia90095
Rika Galias
[email protected]
310-794-4376
Saeed Sadeghi (PRINCIPAL_INVESTIGATOR)
Florida Cancer SpecialistsFort MyersFlorida33901
Pacia Eckert
[email protected]
941-377-9993
Manish Patel (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Jocelyn Tierney
[email protected]
617-632-5136
Antonio Giordano (PRINCIPAL_INVESTIGATOR)
WA Uni School Of MedSt LouisMissouri63110
Mary Halim
[email protected]
314-362-7249
Cynthia Ma (PRINCIPAL_INVESTIGATOR)
Memorial Sloan KetteringNew YorkNew York10017
Josie Anderson
[email protected]
Komal Jhaveri (PRINCIPAL_INVESTIGATOR)
SCRI Oncology PartnersNashvilleTennessee37203
Erika Paige Hamilton (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer Center Uni of TeHoustonTexas77030
Ileana Gutierrez
[email protected]
713-792-2848
Timothy Yap (PRINCIPAL_INVESTIGATOR)
Fred Hutch Cancer ResearchSeattleWashington98109
Ly Tieng Huot
[email protected]
+1 206288 1382
Sara Hurvitz (PRINCIPAL_INVESTIGATOR)

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University of California LA· Los Angeles, CAFlorida Cancer Specialists· Fort Myers, FLDana Farber Cancer Institute· Boston, MAWA Uni School Of Med· St Louis, MOMemorial Sloan Kettering· New York, NYSCRI Oncology Partners· Nashville, TN

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