Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
fulvestrant + abemaciclib + copanlisib
- Development stage
- Unknown
- Lead developer
- Washington University School of Medicine
- Modality
- Small Molecules
- Administration
- Intramuscular, Oral, Intravenous
01
Overview
Fulvestrant + Abemaciclib + Copanlisib (FAC) is an investigational triplet combination therapy developed by Washington University School of Medicine for the treatment of hormone receptor-positive (HR+), HER2-negative metastatic breast cancer that has become resistant to endocrine therapy. The regimen consists of three small molecule targeted agents: fulvestrant, a selective estrogen receptor degrader (SERD) administered intramuscularly; abemaciclib, an oral CDK4/6 inhibitor; and copanlisib, an intravenous PI3K inhibitor with activity against α and δ isoforms. The rationale for this combination is that simultaneously blocking the estrogen receptor, CDK4/6, and PI3K pathways may overcome resistance mechanisms and provide greater efficacy than targeting these pathways individually. A Phase I clinical trial (NCT03939897) evaluated the safety and recommended Phase II dose, but the Phase II portion was removed in late 2023 following Bayer's voluntary withdrawal of the copanlisib NDA.
- Brand names
- Verzenio (abemaciclib)Aliqopa (copanlisib)Faslodex (fulvestrant)
- Other names
- Fulvestrant + Abemaciclib + Copanlisib
02
Targets
PIK3CG (Phosphatidylinositol 4,5-bisphosphate 3-kinase gamma)CDK4 (Cyclin-dependent kinase 4)PIK3CB (Phosphatidylinositol 3-kinase beta subunit)ESR1 (ERα)PIK3CA (Phosphoinositide 3-kinase alpha)PIK3CD (Phosphatidylinositol 3-kinase delta)CDK6 (Cyclin-dependent kinase 6)HIPK3DYRK1A (Dual-specificity tyrosine-phosphorylation-regulated kinase 1A)
Beyond the preview
Go deeper on fulvestrant + abemaciclib + copanlisib.
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Indications & development
Full profile accessExplore development by indication, patient population, and geography.
- Indications
- Development status
- Countries
Licensing & deals
Full profile accessTrace asset ownership, licensing agreements, and commercial partnerships.
- Partners
- Deal terms
- Milestones
Patents & exclusivity
Full profile accessExplore the patent landscape and regulatory exclusivity around an asset.
- Patents
- Expiration dates
- Exclusivity
Competitive landscape
Full profile accessCompare development programs by target, modality, and indication.
- Competing assets
- Targets
- Development stage
Research & analysis
Full profile accessConnect source evidence and development news to your research questions.
- Publications
- News
- Analysis
Bring the full picture into focus.
See how Gosset can support your research on fulvestrant + abemaciclib + copanlisib.