BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
← catalyst calendarSponsored by BeOne Medicines (industry) · ONC — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
33actual
Sites
7
Country
China
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-04-01 | actual | When the study began enrolling |
| Primary completion | 2026-04-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-23 | actual | The whole study's end, after follow-up |
| First posted | 2024-02-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Solid Tumor
- Metastatic Solid Tumor
- Hormone-receptor-positive Breast Cancer
- Breast Cancer
- Metastatic Breast Cancer
- Hormone Receptor Positive Malignant Neoplasm of Breast
- HER2-negative Breast Cancer
Interventions
- Drug: BGB-43395
- Drug: Fulvestrant
- Drug: Letrozole
Primary outcomes
what the primary-completion date above is the date OFPhase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured Up to approximately 30 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395
measured Up to approximately 30 months
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395
measured Up to approximately 30 months
Phase 1b: Objective Response Rate (ORR)
measured Up to approximately 30 months
Permalink · ONC's whole pipeline · Catalyst calendar · Every registered study · What changed