ECI830 / Novartis - LARVOL DELTA

Phase I/II study of the novel CDK2 inhibitor ECI830 as a single agent and in combination with ribociclib (RIB) + fulvestrant (FUL) in patients (pts) with HR+/HER2- advanced breast cancer (ABC) and advanced solid tumors (ESMO-BC 2026) - P1/2 | "Enrollment began in April 2025. ClinicalTrials.gov ID: NCT06726148."

Clinical • Combination therapy • First-in-human • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CCNE1 • CDK4 • HER-2

Selective CDK2 inhibition with ECI830: preclinical characterization, efficacy, and on-target mechanism supported by biomarker and gene signature analysis (AACR 2026) - "While CDK4/6 inhibitors such as ribociclib have transformed the treatment landscape for HR+/HER2− breast cancer, selectively targeting CDK2 has remained challenging due to the high degree of structural similarity to other essential CDK family members, such as CDK1. Moreover, ECI830 showed a favorable pharmacokinetics and tolerability profile in preclinical mouse models. Taken together, these promising preclinical data support ECI830 as a selective and potent CDK2 inhibitor for the treatment of HR+/HER2- breast cancer and other CCNE1-dysregulated advanced solid tumors, which is currently being investigated in clinical trials."

Gene Signature • Preclinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Solid Tumor • CCNE1 • CDK1 • HER-2

ECI830, a potent and highly selective CDK2 inhibitor, for the treatment of HR+/HER2− breast cancer and CCNE1-amplified tumors (AACR 2026) - "In summary, ECI830 is a potent and highly selective CDK2 inhibitor with promising preclinical activity both as a monotherapy (in CCNE1-amplified cancers) and in combination with ribociclib and/or ET (in HR+/HER2− breast cancer). ECI830 is currently being investigated in phase 1 clinical trials as a single agent and in combination with ribociclib and fulvestrant in patients with advanced HR+/HER2- breast cancer and other advanced solid tumors harboring CCNE1 amplification."

Breast Cancer • Eye Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CCNE1 • HER-2

Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor