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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

12 Nov 2025 → ongoing

Decision date (initial)

2025-07-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG

External identifiers

EU CT number

2024-517281-42-00

ClinicalTrials.gov

NCT06726148

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others, Pharmacokinetic, Dose response, Pharmacodynamic

Phase I:

To assess the safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant.

To identify the recommended dose(s) (RD) and/or dose range for optimization (DRO) for further clinical evaluation.

Phase II:

To assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with HR+/HER2- advanced Breast Cancer (aBC) following progression on first-line CDK4/6 inhibitor therapy

Secondary objectives 2

1. Phase I: To characterize the PK of ECI830 (both as a single agent and in combination) and ribociclib (in combination). To evaluate preliminary anti-tumor activity of ECI830 as a single agent and in combination with ribociclib and fulvestrant.
2. Phase II: To further evaluate anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant. To evaluate the contribution of individual study drug to the efficacy of the experimental regimen. To further characterize the safety and tolerability of ECI830 in combination with ribociclib and fulvestrant. To further characterize the PK of ECI830 and ribociclib in combination treatment

Conditions and MedDRA coding

Advanced solid tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age ≥ 18 years old.
2. 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.
3. 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.
4. 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 7

1. Previous treatment with a CDK2 inhibitor at any time.
2. Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.
3. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.
4. Presence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.
5. 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.
6. For patients with Breast Cancer: Patient is concurrently using hormone replacement therapy.
7. Women of child-bearing potential (WOCBP) who are unwilling to use highly effective contraception methods, pregnant or nursing women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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.
2. Phase II: Progression Free Survival (PFS) rate 6 months per local response evaluation criteria in solid tumors (RECIST v1.1).

Secondary endpoints 2

1. 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.
2. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 7

Locations

6 EU/EEA countries · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 54 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications