Clinical trial • Phase I/II • Oncology
ECI830 for Hormone receptor positive HER2 negative breast cancer|Advanced solid tumors
Phase I/II trial of ECI830 for Hormone receptor positive HER2 negative breast cancer|Advanced solid tumors.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Hormone receptor positive HER2 negative breast cancer|Advanced solid tumors
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 03-04-2025
- First CTIS Authorization Date
- 29-07-2025
Trial design
open-label, none/not specified-controlled, adaptive Phase I/II trial across 12 sites in Czechia, Germany, Spain and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation elements described: Phase I aims to assess safety/tolerability and identify recommended dose(s) (RD) and/or dose range for optimization (DRO) for further evaluation (i.e. escalation and dose-finding with expansion cohorts).
- Biomarker Stratified
- True, CCNE1 amplification (patients with histologically and/or cytologically confirmed locally advanced or metastatic cancer with a CCNE1 amplification are eligible in Phase I).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 62
- Trial Duration For Participant
- 1096
Eligibility
Recruits 62 isVulnerablePopulationSelected=true. Informed consent is required via adult ICFs (multiple country-specific adult ICFs are included). A 'Parent Legal Guardian' ICF document is present in the document list (French NonRed), indicating provision for consent by a legal guardian where applicable; however the protocol inclusion criteria specify Age ≥ 18 years. No explicit assent procedures for minors are provided in the available data..
- Pregnancy Exclusion
- Women of child-bearing potential (WOCBP) who are unwilling to use highly effective contraception methods, pregnant or nursing women.
- Vulnerable Population
- isVulnerablePopulationSelected=true. Informed consent is required via adult ICFs (multiple country-specific adult ICFs are included). A 'Parent Legal Guardian' ICF document is present in the document list (French NonRed), indicating provision for consent by a legal guardian where applicable; however the protocol inclusion criteria specify Age ≥ 18 years. No explicit assent procedures for minors are provided in the available data.
Inclusion criteria
- {"criterion_text":"- Age ≥ 18 years old.\n- Phase I - Patients with one of the following indications: 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.\n- Phase II - Patients with the following indication: 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.\n- Measurable disease as determined by RECIST v1.1. Breast Cancer 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
- {"criterion_text":"- Previous treatment with a CDK2 inhibitor at any time.\n- Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.\n- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.\n- Presence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.\n- 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.\n- For patients with Breast Cancer: Patient is concurrently using hormone replacement therapy.\n- Women of child-bearing potential (WOCBP) who are unwilling to use highly effective contraception methods, pregnant or nursing women."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Phase I: Safety – Incidence and severity of dose-limiting toxicities (DLTs), adverse events (AEs) and serious adverse events (SAEs), including changes in lab values, vital signs, electrocardiograms (ECGs). Tolerability – Frequency of dose interruptions, reductions, discontinuations.","definition_or_measurement_approach":"Safety and tolerability assessed by incidence and severity of DLTs, AEs and SAEs, including laboratory values, vital signs and ECG changes; tolerability by frequency of dose interruptions, reductions and discontinuations."}
- {"endpoint_text":"- Phase II: Progression Free Survival (PFS) rate 6 months per local response evaluation criteria in solid tumors (RECIST v1.1).","definition_or_measurement_approach":"PFS at 6 months determined by local assessment according to RECIST v1.1."}
Secondary endpoints
- {"endpoint_text":"- Phase I: Plasma concentrations of ECI830, ribociclib, and derived PK parameters including area under the curve (AUC) and maximum plasma concentration (Cmax). Overall response rate (ORR), best overall response (BOR), disease control rate (DCR), clinical benefit rate (CBR) and PFS per local RECIST v1.1.","definition_or_measurement_approach":"Pharmacokinetics: plasma concentrations and derived PK parameters (AUC, Cmax). Efficacy measures: ORR, BOR, DCR, CBR, PFS assessed locally per RECIST v1.1."}
- {"endpoint_text":"- Phase II: ORR, BOR, PFS, DCR, CBR, duration of response (DOR) as per local RECIST v1.1, and overall survival (OS). Safety - Incidence and severity of AEs, SAEs, including changes in lab values, vital signs, ECGs. Tolerability: Frequency of dose interruptions, reductions, and discontinuations. Plasma concentration of ECI830, ribociclib, and derived PK parameters including AUC and Cmax.","definition_or_measurement_approach":"Efficacy endpoints (ORR, BOR, PFS, DCR, CBR, DOR) and OS assessed locally per RECIST v1.1. Safety assessed by incidence/severity of AEs/SAEs and clinical/lab/ECG changes. PK endpoints: plasma concentrations and AUC/Cmax."}
Recruitment
- Planned Sample Size
- 62
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent obtained using country-specific adult ICFs (multiple 'L1_ICF - Main ICF - Adult' documents are present for Czech, Germany, Spain, Denmark, Italy, France). Additional consent-related documents present include Separate Data Protection Consent and optional consent modules. ICFs are provided in local languages for participating countries (Czech, German, Spanish, Danish, Italian, French, English procedure documents), indicating consent materials are available in multiple languages. A 'Parent Legal Guardian' ICF document is present (French NonRed) but the protocol eligibility requires Age ≥ 18.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 59
Czechia
- Earliest CTIS Part Ii Submission Date
- 25-06-2025
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 225
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- 3001:Klinika komplexni onkologicke pece
- Principal Investigator Name
- Peter Grell
- Principal Investigator Email
- grell@mou.cz
- Contact Person Name
- Peter Grell
- Contact Person Email
- grell@mou.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 30-06-2025
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 220
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- 3301:Comprehensive Cancer Center Ulm (CCCU) / Early Clinical Trial Unit (ECTU)
- Principal Investigator Name
- Sabine Heublein
- Principal Investigator Email
- Sabine.Heublein@uniklinik-ulm.deProf
- Contact Person Name
- Sabine Heublein
- Contact Person Email
- Sabine.Heublein@uniklinik-ulm.deProf
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- 3303: Duque Afonso Klinik für Innere Medizin I
- Principal Investigator Name
- Jesus Duque Afonso
- Principal Investigator Email
- Jesus.duque.afonso@uniklinik-freiburg.de
- Contact Person Name
- Jesus Duque Afonso
- Contact Person Email
- Jesus.duque.afonso@uniklinik-freiburg.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- 3302:Nationales Centrum für Tumorerkrankungen (NCT)
- Principal Investigator Name
- Carlo Fremd
- Principal Investigator Email
- Carlo.fremd@med.uni-heidelberg.de
- Contact Person Name
- Carlo Fremd
- Contact Person Email
- Carlo.fremd@med.uni-heidelberg.de
Spain
- Earliest CTIS Part Ii Submission Date
- 24-07-2025
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 197
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- 3501:Oncology
- Principal Investigator Name
- Alberto Hernando Calvo
- Principal Investigator Email
- ahernando@vhio.net
- Contact Person Name
- Alberto Hernando Calvo
- Contact Person Email
- ahernando@vhio.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- 3502:Oncology
- Principal Investigator Name
- Ivan Manuel Victoria Ruiz
- Principal Investigator Email
- ivictori@recerca.clinic.cat
- Contact Person Name
- Ivan Manuel Victoria Ruiz
- Contact Person Email
- ivictori@recerca.clinic.cat
Denmark
- Earliest CTIS Part Ii Submission Date
- 30-06-2025
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 219
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Odense University Hospital
- Department Name
- 3102:Onkologisk Afdeling R
- Principal Investigator Name
- Annette Raskov Kodahl
- Principal Investigator Email
- annette.kodahl@rsyd.dk
- Contact Person Name
- Annette Raskov Kodahl
- Contact Person Email
- annette.kodahl@rsyd.dk
- Site Name
- Rigshospitalet
- Department Name
- 3101:Fase 1/Forsøgsbehandling Afdeling for Kræftbehandling
- Principal Investigator Name
- Martin Hoejgaard
- Principal Investigator Email
- martin.hoejgaard@regionh.dk
- Contact Person Name
- Martin Hoejgaard
- Contact Person Email
- martin.hoejgaard@regionh.dk
Italy
- Earliest CTIS Part Ii Submission Date
- 25-04-2025
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 287
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- 3401;Divisione Sviluppo Nuovi Farmaci per Terapie Innovative - Oncologia Medica
- Principal Investigator Name
- Giuseppe CURIGLIANO
- Principal Investigator Email
- giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe CURIGLIANO
- Contact Person Email
- giuseppe.curigliano@ieo.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- 3402;S.C. di Oncologia Dip di Oncologia ed Ematologia
- Principal Investigator Name
- Annalisa FONTANA
- Principal Investigator Email
- fontana.annalisa@policlinico.mo.it
- Contact Person Name
- Annalisa FONTANA
- Contact Person Email
- fontana.annalisa@policlinico.mo.it
France
- Earliest CTIS Part Ii Submission Date
- 26-05-2025
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 281
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Institut Bergonie
- Department Name
- 3202:Medical Oncology
- Principal Investigator Name
- Monica ARNEDOS
- Principal Investigator Email
- m.arnedos@bordeaux.unicancer.fr
- Contact Person Name
- Monica ARNEDOS
- Contact Person Email
- m.arnedos@bordeaux.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- 3201:Medical Oncology
- Principal Investigator Name
- Mario CAMPONE
- Principal Investigator Email
- mario.campone@ico.unicancer.fr
- Contact Person Name
- Mario CAMPONE
- Contact Person Email
- mario.campone@ico.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties: code 1
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties: code 7
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties: code 1; code 13; code 3
- Name
- Q Squared Solutions Limited
- Responsibilities
- Central Lab (sponsorDuties code 15)
- Name
- Veeda Clinical Research Limited
- Responsibilities
- PK analysis for ECI830 and LEE011 (sponsorDuties code 15) and code 4
- Name
- Syneos Health Inc.
- Responsibilities
- sponsorDuties: code 1
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties: code 1; code 12
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties: code 1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties: code 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties: code 1; code 13; code 3","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central Lab (sponsorDuties code 15, value: Central Lab)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"India","full_name":"Veeda Clinical Research Limited","duties_or_roles":"sponsorDuties: code 15 (ECI830 and LEE011 Pharmacokinetics (PK) analysis); code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties: code 1","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties: code 1; code 12","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ECI830
- Active Substance
- ECI830
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus=1
- Investigational Product Name
- RIBOCICLIB
- Active Substance
- RIBOCICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus=2
- Investigational Product Name
- FULVESTRANT
- Active Substance
- FULVESTRANT
- Modality
- Small molecule
- Routes Of Administration
- INTRAMUSCULAR INJECTION
- Route
- INTRAMUSCULAR INJECTION
- Authorisation Status
- prodAuthStatus=2
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)