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NCT06726148 | RECRUITING | Advanced HR+/HER2- Breast Cancer

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

Novartis Pharmaceuticals

Brief Summary:

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.

Condition or disease

Advanced HR+/HER2- Breast Cancer

Advanced CCNE1-amplified Solid Tumors

Intervention/treatment

ECI830

ribociclib

fulvestrant

Phase

PHASE1

PHASE2

Detailed Description:

This is a first-in-human, open-label, phase I/II, multi-center study consisting of an ECI830 single agent treatment arm in patients with advanced HR+/HER2- breast cancer or other advanced solid tumors harboring CCNE1 amplification and a combination treatment arm of ECI830 with ribociclib and fulvestrant in patients with advanced breast cancer. Single agent escalation may be followed by an expansion part stratified by disease indication. The escalation of the combination arm may continue into a randomized, open label, Phase II with optional dose optimization in advanced breast cancer patients.

Study Type : INTERVENTIONAL
Estimated Enrollment : 280 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors
Actual Study Start Date : 2025-04-03
Estimated Primary Completion Date : 2028-09-25
Estimated Study Completion Date : 2028-09-25

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • Age ≥ 18 years old.
  • Patients with one of the following indications
    • Phase I
      • HR+/HER2- aBC with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4/6i and at least one additional line of systemic therapy for metastatic disease.
      • Histologically and/or cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.
      • Phase II
        • HR+/HER2- aBC with disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4/6 inhibitor for unresectable/metastatic disease with no more than 2 lines of endocrine therapy.
        • Measurable disease as determined by RECIST v1.1.
        • BC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.
        Exclusion Criteria
        • Previous treatment with a CDK2 inhibitor at any time.
        • Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.
        • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.
        • Presence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.
        • For the combination treatment
          • Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.
          • Patients who could not tolerate the prescribed dose of ribociclib during a previous course of treatment, requiring dose reduction or permanent discontinuation due to adverse events.
          • For patients with BC: Patient is concurrently using hormone replacement therapy.
          • WOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women.
          • Other protocol-defined inclusion/exclusion criteria may apply.
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Location Details

NCT06726148

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Florida Cancer Specialists

Fort Myers, Florida, United States, 33901

RECRUITING

United States, Missouri

WA Uni School Of Med

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, Tennessee

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

MD Anderson Cancer Center Uni of Te

Houston, Texas, United States, 77030

RECRUITING

Australia, Victoria

Novartis Investigative Site

Clayton, Victoria, Australia, 3168

RECRUITING

Australia, Victoria

Novartis Investigative Site

Melbourne, Victoria, Australia, 3004

RECRUITING

Canada, Ontario

Novartis Investigative Site

Toronto, Ontario, Canada, M5G 2M9

RECRUITING

Israel,

Novartis Investigative Site

Haifa, Israel, 3109601

RECRUITING

Israel,

Novartis Investigative Site

Tel Aviv, Israel, 6423906

RECRUITING

Japan, Tokyo

Novartis Investigative Site

c or library, Tokyo, Japan, 104 0045

RECRUITING

Korea, Republic of,

Novartis Investigative Site

Seoul, Korea, Republic of, 03080

RECRUITING

Singapore,

Novartis Investigative Site

Singapore, Singapore, 119074

RECRUITING

Taiwan,

Novartis Investigative Site

Tainan, Taiwan, 704