Clinical Trials List
Protocol NumberCECI830A12101
NCT Number(ClinicalTrials.gov Identfier)NCT06726148
Active
2025-04-25 - 2029-02-28
Phase I/II
Recruiting1
ICD-10C50.911
Malignant neoplasm of unspecified site of right female breast
ICD-10C50.912
Malignant neoplasm of unspecified site of left female breast
ICD-10C50.919
Malignant neoplasm of unspecified site of unspecified female breast
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9174.9
Malignant neoplasm of female breast, unspecified
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
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Principal Investigator
Wei-Pang Chung
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced HR+/HER2- Breast Cancer、 Advanced CCNE1-amplified Solid Tumors
Objectives
Phase I: Describe the safety and tolerability of ECI830 as monotherapy and in combination with ribociclib and fulvestrant. Identify the optimal dose range/recommended dose for future trials.
Phase II: Evaluate the antitumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor (HR) positive (+)/human epidermal growth factor receptor 2 (HER2) negative (-) advanced breast cancer.
Test Drug
膠囊劑
Active Ingredient
ECI830
Dosage Form
130
Dosage
10MG, 50MG
Endpoints
Phase I:
Safety: Incidence and severity of dose-limiting toxicities (DLT), adverse events (AEs), and serious adverse events (SAEs), including changes in laboratory test values, vital signs, and electrocardiogram (ECG).
Tolerability: Frequency of dosing interruptions, dose reductions, and treatment discontinuations.
Phase II: 6-month progression-free survival (PFS) according to local criteria for evaluating response to solid tumors, version 1.1 (RECIST v1.1).
Safety: Incidence and severity of dose-limiting toxicities (DLT), adverse events (AEs), and serious adverse events (SAEs), including changes in laboratory test values, vital signs, and electrocardiogram (ECG).
Tolerability: Frequency of dosing interruptions, dose reductions, and treatment discontinuations.
Phase II: 6-month progression-free survival (PFS) according to local criteria for evaluating response to solid tumors, version 1.1 (RECIST v1.1).
Inclution 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.
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
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.
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.
The Estimated Number of Participants
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Taiwan
6 participants
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Global
120 participants
