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Phase 1Recruiting

First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer

Sponsored by Accent Therapeutics

About this study

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 in patients with advanced solid tumors and ovarian 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 and triple negative breast cancer. This is a first-in-human, Phase 1, open-label, single-arm, dose-escalation and Simon 2-Stage expansion study to evaluate the safety profile of ATX-295 and determine the recommended phase 2 dose (RP2D). In addition, the study aims to characterize the PK, PD, and preliminary anti-tumor activity of orally administered ATX-295. Exploratory obje…

Where this study is enrolling (9)

Show all 9 locations
Who can participate

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 expansion cohorts, participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, platinum-refractory, or platinum-intolerant
  • ✓There is no limit to the number of prior treatment regimens
  • ✓Have measurable or evaluable disease
  • ✓Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion criteria

  • ✕Clinically unstable central nervous system (CNS) tumors or brain metastasis
  • ✕Any other concurrent anti-cancer treatment, except for hormonal blockade
  • ✕Has undergone a major surgery within 3 weeks of starting study treatment
  • ✕Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-295, however participants with a functioning distal ileostomy or colostomy may be permitted on trial
  • ✕Clinically significant (ie, active) or uncontrolled cardiovascular disease
  • ✕Need to use proton pump inhibitors on study or H2-receptor antagonists for the dose escalation portion of the study.
  • ✕Unable to transition off strong or moderate CYP3A4 inhibitors or strong inducers
  • ✕Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment
  • ✕Other inclusion and exclusion criteria as defined in the study protocol

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.