First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, as Monotherapy and in Combination With Anticancer Therapy in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer

Prior treatment

• Any other concurrent anti-cancer treatment, except for hormonal blockade
• Has undergone a major surgery within 3 weeks of starting study treatment
• 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

Other illness

• 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

Other

• Clinically unstable central nervous system (CNS) tumors or brain metastasis
• 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

• 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 determined to be platinum-resistant, or platinum-intolerant
• Participants with sqNSCLC should have received prior treatment with a platinum, taxane, and checkpoint inhibitor
• For the combination with bevacizumab (or biosimilar): Participants must have histologically confirmed HGSOC or select solid tumors
• There is no limit to the number of prior treatment regimens
• Have measurable disease; evaluable disease is acceptable during dose escalation
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1