BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
← catalyst calendarNCT06120283 · readout ≤ 834 d
Sponsored by BeOne Medicines (industry) · ONC — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
399estimated
Sites
62
Countries
Australia, Brazil, China +8
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 | 2023-12-01 | actual | When the study began enrolling |
| Primary completion | Nov 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2023-11-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-19 | 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
- Advanced Breast Cancer
- Metastatic Breast Cancer
- Hormone-receptor-positive Breast Cancer
- Hormone Receptor Positive Breast Carcinoma
- Hormone Receptor Positive Malignant Neoplasm of Breast
- HER2-negative Breast Cancer
- Hormone Receptor Positive HER-2 Negative Breast Cancer
- Non-small Cell Lung Cancer
Interventions
- Drug: BGB-43395
- Drug: Fulvestrant
- Drug: Letrozole
- Drug: Elacestrant
- Drug: Anti-Diarrheal Agent
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 60 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395
measured Up to approximately 60 months
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395
measured Up to approximately 60 months
Phase 1b: Objective Response Rate (ORR)
measured Up to approximately 60 months
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