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BGB-43395

DRUG9 trials

Sponsors

BeOne Medicines I GmbH, BeOne Medicines, BeiGene

Conditions

Advanced Breast CancerAdvanced Solid TumorAdvanced or Metastatic HR+/HER2- Breast CancerBladder CancerBreast CancerEndometrial CancerGastric CancerGastroEsophageal Cancer

Phase 1

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
RecruitingNCT06120283
BeOne MedicinesAdvanced Breast Cancer, Advanced Solid Tumor, HER2-negative Breast Cancer +5
Start: 2023-12-01End: 2029-12-01Target: 433Updated: 2026-09-11
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
CompletedNCT06253195
BeOne MedicinesAdvanced Solid Tumor, Breast Cancer, HER2-negative Breast Cancer +4
Start: 2024-04-01End: 2026-04-23Updated: 2026-06-10
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
Active, not recruitingNCT06257264
BeiGeneAdvanced Solid Tumor, Bladder Cancer, Breast Cancer +9
Start: 2024-03-11End: 2026-08-31Updated: 2026-06-18
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
RecruitingNCT06756932
BeOne MedicinesHER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Metastatic Breast Cancer
Start: 2025-02-04End: 2027-07-30Target: 120Updated: 2026-09-14
A Study of Different Forms of BGB-43395 and Food Effect in Healthy Participants
CompletedNCT06761898
BeiGeneHealthy Volunteers
Start: 2025-01-14End: 2025-05-20Updated: 2025-09-04
A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
RecruitingNCT07226349
BeOne MedicinesAdvanced Solid Tumor
Start: 2025-12-11End: 2028-11-01Target: 105Updated: 2026-09-11
A Trial in Healthy Participants to Assess Drug Interaction Potential of BGB-43395
Not yet recruitingNCT07820891
BeOne MedicinesHealthy Adult Participants
Start: 2026-09-24End: 2026-11-22Target: 24Updated: 2026-09-15

Phase 3

BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
RecruitingNCT07492641
BeOne MedicinesHR+/HER2- Breast Cancer
Start: 2026-05-22End: 2037-08-07Target: 1056Updated: 2026-09-15
An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease
Not yet recruitingCTIS2025-523960-19-00
BeOne Medicines I GmbHAdvanced or Metastatic HR+/HER2- Breast Cancer
Target: 98Updated: 2026-07-27

Related Papers

First disclosure of frontline treatment (1L tx) with the selective CDK4 inhibitor BGB-43395 in combination with letrozole for metastatic HR+/HER2− breast cancer (BC): A phase 1 safety expansion.
Journal of Clinical Oncology2026-05-27
Abstract 4663: BGB-21447, a next-generation Bcl-2 inhibitor, demonstrates superior potency and overcomes Venetoclax resistance in preclinical models of hematologic malignancies
Cancer Research2026-04-03
Abstract PS5-07-29: Trial in progress: a phase 1 dose-escalation study evaluating BGB-21447 (BCL2 inhibitor) in combination with fulvestrant with and without BGB-43395 (CDK4 inhibitor) in patients with previously treated HR+/HER2− metastatic breast cancer
Clinical Cancer Research2026-02-17
Abstract P4-10-06: Preclinical characterization of BGB-43395, a potential best-in-class CDK4 selective inhibitor with potent pharmacodynamic and anti-tumor activity in HR+HER2- breast cancer models
Clinical Cancer Research2025-06-131 citations
Abstract P4-12-29: ETX-197/BG-68501, a potential best-in-class potent, selective, oral, small molecule CDK2 inhibitor, has anti-tumor activity in cancer models with Cyclin E amplification or deficiency in the Retinoblastoma 1 gene
Clinical Cancer Research2025-06-131 citations
Abstract P4-08-20: Trial in progress: A first-in-human phase 1a/b, dose-escalation/expansion study of BG-68501/ETX-197 (CDK2 inhibitor) as monotherapy or in combination with fulvestrant for patients with HR+/HER2- breast cancer and other advanced solid tumors
Clinical Cancer Research2025-06-13
Abstract P4-08-26: Trial in progress: First-in-human phase 1a/1b, dose-escalation/expansion study of BGB-43395 (CDK4 selective inhibitor) as monotherapy or combination therapy in Chinese patients with metastatic HR+/HER2- breast cancer & other advanced solid tumors
Clinical Cancer Research2025-06-13
Abstract P4-10-20: First-in-human phase 1a, dose-escalation study of BGB-43395 (CDK4-selective inhibitor) as monotherapy and in combination with fulvestrant or letrozole in patients with metastatic HR+/HER2+ breast cancer and other advanced solid tumors
Clinical Cancer Research2025-06-13
A first-in-human, phase 1a/b, dose-escalation/expansion study of BG-68501, a selective CDK2 inhibitor, as monotherapy or in combination with fulvestrant for patients with HR+/HER2- breast cancer and other advanced solid tumors: First disclosure of clinical data.
Journal of Clinical Oncology2025-05-28