Accent Therapeutics
The goal of this study is to identify a safe and tolerated dose of the orally administered KIF18A inhibitor ATX-295. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ATX-295 as a monotherapy and in combination with bevacizumab (or a biosimilar) in patients with locally advanced or metastatic solid tumors, including ovarian cancer and lung cancer.
ATX-295 is an oral drug that inhibits a protein called KIF18A, an adenosine triphosphate (ATP)-dependent, plus end-directed mitotic kinesin. KIF18A facilitates chromosomal alignment and spindle microtubule dynamics during mitosis in certain advanced solid tumors. ATX-295 has been shown preclinically to induce robust anti-tumor activity of a variety of different solid tumors, including high-grade serious ovarian cancer, squamous non-small cell lung cancer, and triple negative breast cancer. This is a first-in-human, Phase 1, open-label, single-arm, dose-escalation and Simon 2-Stage expansion s…
Key Inclusion Criteria: * Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease, including HGSOC * Refractory to or relapsed after all standard therapies with proven clinical benefit, unless as deemed by the Investigator, the subject is not a candidate for standard treatment, there is no standard treatment, or the subject refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit * For the monotherapy expansion cohorts: * Participants must have histological confirmation of HGSOC and be det…
ATX-295 tablets will be taken orally
ATX-295 tablets will be taken orally in combination with bevacizumab (or biosimilar) administered via intravenous infusion