Drugs / BGB-43395
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT07820891 | Sep → Nov 2026 expected | — | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1 | NCT07226349 | Dec 2025 → Nov 2028 expected | neoplasm | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1 | NCT06756932 | Feb 2025 → Jul 2027 expected | hormone receptor-positive breast cancer | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1 | NCT06761898 | Jan → May 2025 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT06253195 | Apr 2024 → Apr 2026 | hormone receptor-positive breast cancer, metastatic neoplasm | BeOne Medicines | Completed | No outcome recorded |
| Phase 1 | NCT06257264 | Mar 2024 → Aug 2026 overdue | endometrial cancer, gastric cancer, gastroesophageal cancer, hormone receptor-positive breast cancer +5 | BeiGene | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06120283 | Dec 2023 → Dec 2029 expected | hormone receptor-positive breast cancer | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07492641 | May 2026 → Apr 2029 expected | hormone receptor-positive breast cancer | BeOne Medicines | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | BeOne Medicines | Results BeOne Medicines Highlights Accelerating Solid Tumor Pipeline with New Data at ASCO 2026 beonemedicines.com ↗
The 240 mg dose of BGB-43395 plus letrozole resulted in a confirmed overall response rate (ORR) of 68.4% (95% CI: 43.4–87.4) and unconfirmed ORR of 73.7% (95% CI: 48.8-90.9). |
| 2025-06-26 | BeOne Medicines | Results BeOne Medicines Showcases Groundbreaking Oncology Pipeline at R&D Day beonemedicines.com ↗
In solid tumors, the Company is advancing multiple targeted modalities beyond its foundational PD-1 inhibitor TEVIMBRA® (tislelizumab-jsgr), including CDK4 inhibitor BGB-43395, which has shown clear pharmacodynamic activity and is expected to enter registration-enabling studies for the treatment of breast cancer within the next six to 12 months. |
| 2024-12-12 | BeOne Medicines | Results BeiGene Unveils Breast Cancer Pipeline beonemedicines.com ↗
To date, the results indicate that BGB-43395 has been generally well tolerated across different dose levels, with encouraging early signs of clinical activity emerging. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | BeOne Medicines | BeOne Medicines Highlights Accelerating Solid Tumor Pipeline with New Data at ASCO 2026 beonemedicines.com ↗ |
| 2025-06-26 | BeOne Medicines | BeOne Medicines Showcases Groundbreaking Oncology Pipeline at R&D Day beonemedicines.com ↗ |
| 2024-12-12 | BeOne Medicines | BeiGene Unveils Breast Cancer Pipeline beonemedicines.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BGB-43395 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06756932 ↗ |
| Action | Inhibit | “CDK4 Inhibitor” NCT06120283 ↗ |
| Route | Oral | “Planned doses administered orally.” NCT06120283 ↗ |
| Target | CDK4 | “CDK4 Inhibitor” NCT06120283 ↗ |