eciruciclib (BPI-1178) / Beta Pharma - LARVOL DELTA

Compare the Data Differences between Dosing Groups in Patients with Advanced or Recurrent HR+/HER2- Breast Cancer Treated with Ecirciclib (BPI-1178) Combined with Endocrine Therapy (SABCS 2025) - "Background: Eciruciclib (BPI-1178) is a novel cyclin-dependent kinase (CDK) 2/4/6 inhibitor that has demonstrated potent inhibition of CDK2/4/6 expression in preclinical studies. Phase IIa had two cohorts, A and B. Cohort A included patients with HR+/HER2- advanced breast cancer (ABC) who progressed after endocrine therapy (ET) and were treated with eciruciclib and fulvestrant. In contrast, treatment-naive patients with HR+/HER2- ABC in cohort B received eciruciclib and letrozole... Under equivalent theoretical dosage, different administration regimens vary in efficacy but have comparable safety, offering valuable references for selecting the optimal dosing strategy in subsequent phases."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A phase I/IIa study to evaluate the tolerability, safety, pharmacokinetics and efficacy of eciruciclib (BPI-1178) alone in advanced solid tumors and in combination with endocrine therapy for advanced or recurrent HR+/HER2- breast cancer. (ASCO 2025) - P1/2 | "Phase IIa consisted of two cohorts, A and B. Cohort A included patients with HR+/HER2- ABC who had progressed after ET receiving eciruciclib in combination with fulvestrant, and treatment-naive patients with HR+/HER2- ABC in cohort B were treated with eciruciclib in combination with letrozole. Eciruciclib in combination with ET demonstrated promising efficacy and manageable safety profile in patients with HR+/HER2- ABC. a intermittent dosing schedule; b continuous dosing schedule; NR, not reached."

Clinical • Combination therapy • Metastases • P1/2 data • PK/PD data • Breast Cancer • Dyslipidemia • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Hypertriglyceridemia • Oncology • Solid Tumor • CDK2 • HER-2

A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer (clinicaltrials.gov) - P1/2 | N=224 | Recruiting | Sponsor: Beta Pharma (Suzhou) Co., Ltd. | Trial completion date: Mar 2024 ➔ Jun 2025 | Trial primary completion date: Mar 2024 ➔ Dec 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

BPI-1178-IIT01: A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: National Cancer Center, China | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: National Cancer Center, China

Combination therapy • Metastases • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer (clinicaltrials.gov) - P1/2 | N=224 | Recruiting | Sponsor: Beta Pharma (Suzhou) Co., Ltd. | N=122 ➔ 224 | Trial primary completion date: Jun 2023 ➔ Mar 2024

Combination therapy • Enrollment change • Metastases • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer (clinicaltrials.gov) - P1/2; N=122; Recruiting; Sponsor: Beta Pharma (Suzhou) Co., Ltd.; Trial primary completion date: Sep 2022 ➔ Jun 2023

Clinical • Combination therapy • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer (clinicaltrials.gov) - P1/2; N=100; Recruiting; Sponsor: Beta Pharma (Suzhou) Co., Ltd.; Not yet recruiting ➔ Recruiting; Initiation date: Mar 2020 ➔ Jun 2020

Clinical • Combination therapy • Enrollment open • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer (clinicaltrials.gov) - P1/2; N=100; Not yet recruiting; Sponsor: Beta Pharma (Suzhou) Co., Ltd.

Clinical • Combination therapy • New P1/2 trial