RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Accent Therapeutics • ClinicalTrials.gov ID: NCT06799065

Registry updated: 2026-10-13

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Description

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.

Interventions

ATX-295 (Drug)
ATX-295 tablets will be taken orally
ATX-295 and bevacizumab (or biosimilar) (Drug)
ATX-295 tablets will be taken orally in combination with bevacizumab (or biosimilar) administered via intravenous infusion

Eligibility criteria

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 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 Key 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

Conditions

Advanced Solid Tumors Breast Cancer Recurrent Ovarian Cancer High-grade Serous Ovarian Carcinoma Triple Negative Breast Cancer sqNSCLC Squamous Non-small-cell Lung Cancer

Locations

University of Colorado Denver — Aurora, Colorado, United States
Florida Cancer Specialists — Sarasota, Florida, United States
Karmanos Cancer Institute — Detroit, Michigan, United States
Washington University — St Louis, Missouri, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
NYU Longone Health (Long Island) — Long Island City, New York, United States
NYU Longone Health (Manhattan) — Manhattan, New York, United States
SCRI Oncology Partners — Nashville, Tennessee, United States
MD Anderson Cancer Center — Houston, Texas, United States
NEXT Oncology — San Antonio, Texas, United States
NEXT Virginia — Fairfax, Virginia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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