Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
OKI-219 + fulvestrant
- Development stage
- Unknown
- Lead developer
- OnKure Therapeutics
- Modality
- Small Molecules
- Administration
- Oral, Intramuscular
01
Overview
**OKI-219 + fulvestrant** is an investigational combination therapy under clinical evaluation for hormone receptor-positive (HR+), HER2-negative, locally advanced, unresectable, or metastatic breast cancer harboring the PI3Kα H1047R mutation. OKI-219 is a small molecule, highly selective, mutant-specific inhibitor of PI3K alpha (phosphoinositide 3-kinase catalytic subunit alpha) targeting the H1047R mutation, developed to overcome resistance and enhance efficacy of endocrine therapies. Fulvestrant is a selective estrogen receptor degrader (SERD) that antagonizes and degrades the estrogen receptor. In combination, OKI-219 inhibits oncogenic PI3K signaling in mutant tumor cells, while fulvestrant blocks estrogen receptor-dependent proliferation, aiming for synergistic antitumor effects.
- Other names
- OKI-219 + fulvestrant
02
Targets
PIK3CA H1047R (Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), H1047R mutant)ESR1 (ERα)
Beyond the preview
Go deeper on OKI-219 + fulvestrant.
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 OKI-219 + fulvestrant.