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INX-315 + fulvestrant is an investigational combination therapy under clinical evaluation for advanced or metastatic cancers. INX-315 is an oral, potent, and selective small molecule inhibitor of cyclin dependent kinase 2 (CDK2), which is implicated in cell cycle progression and resistance to CDK4/6 inhibitors in cancers with CCNE1 amplification, such as high-grade serous ovarian cancer and ER+/HER2- breast cancer. Fulvestrant is an estrogen receptor antagonist and a selective estrogen receptor degrader (SERD), approved for hormone receptor-positive breast cancer; it binds, blocks, and promotes degradation of the estrogen receptor. The combination aims to simultaneously inhibit cell cycle progression (via CDK2 inhibition) and hormone-driven tumor growth (via estrogen receptor antagonism/degradation), particularly targeting patients who have progressed on CDK4/6 inhibitors and/or endocrine therapies[1][3][5][7][8].
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