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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedATX-295 and ATX-295 and bevacizumab (or biosimilar)

The study team can explain what participation involves.

Who it may be forLocally advanced · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 25, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?Accent Therapeutics

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Accent Therapeutics
Interventions being studied: Drug: ATX-295; Drug: ATX-295 and bevacizumab (or biosimilar)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Locally advanced→Metastatic or stage IV→Recurrent or relapsed→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key
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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Colorado DenverAurora, Colorado
Florida Cancer SpecialistsSarasota, Florida
Karmanos Cancer InstituteDetroit, Michigan
University of Nebraska Medical CenterOmaha, Nebraska
NYU Longone Health (Long Island)Long Island City, New York
NYU Longone Health (Manhattan)Manhattan, New York
SCRI Oncology PartnersNashville, Tennessee
MD Anderson Cancer CenterHouston, Texas
NEXT OncologySan Antonio, Texas
NEXT VirginiaFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 25, 2026. Always confirm current availability with the study team.

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