BPI-16350

DRUG3 trials

Sponsors

Betta Pharmaceuticals Co., Ltd.

Conditions

Advanced Solid CancerBreast CancerHealthy

Phase 1

A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor

Active, not recruitingNCT03791112

Betta Pharmaceuticals Co., Ltd.Advanced Solid Cancer

Start: 2019-07-18End: 2025-12-31Target: 54Updated: 2025-01-27

A Food-Effect Study of BPI-16350 in Healthy Subjects

CompletedNCT05316259

Betta Pharmaceuticals Co., Ltd.Healthy

Start: 2022-04-15End: 2022-08-30Updated: 2023-05-09

Phase 3

A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer

Betta Pharmaceuticals Co., Ltd.Breast Cancer

Start: 2022-05-25End: 2025-07-31Updated: 2023-07-27

Related Papers

Tibremciclib or Placebo Plus Fulvestrant in Hormone Receptor–Positive and <i>ERBB2</i>-Negative Advanced Breast Cancer After Endocrine Therapy

JAMA Oncology2025-07-311 citations

Abstract PS2-02: Tibremciclib (BPI-16350) plus fulvestrant versus placebo plus fulvestrant for patients with HR+/HER2- advanced breast cancer after progressing on endocrine therapy: Updated analysis of the phase III study

Clinical Cancer Research2025-06-131 citations

A phase I dose-escalation and dose-expansion study of tibremciclib, a novel CDK4/6 inhibitor, monotherapy and in combination with fulvestrant in HR-positive/HER2-negative advanced breast cancer.

2025-05-21

BPI-16350, a novel promising CDK4/6 inhibitor for HR+/HER2- metastatic breast cancer (MBC): Results from a phase I study.

Journal of Clinical Oncology2023-06-015 citations