Summary
Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin
dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is
designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary
antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer,
including hormone receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative
(HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4/6 inhibitor
(CDK4/6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care
treatment. This study will evaluate approximately 6 dose levels of daily INX-315 in Part A,
at least two dose levels will be evaluated in Part B to identify the Recommended Phase 2 Dose
(RP2D) in patients with ovarian cancer, and Part C will evaluate combination treatment of
INX-315 plus a CDK4/6i and selective estrogen receptor degrader (SERD) in HR+/HER2- breast
cancer patients who have progressed on prior CDK4/6i regimen.