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

February 21, 2026 updated by: Accent Therapeutics

A Phase 1/2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-295, an Oral Inhibitor of the Kinesin Motor Protein KIF18A, in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 objectives include examination of biomarker responses in relationship to ATX-295 exposure.

Patients with locally advanced or metastatic solid tumors will be enrolled to preliminarily assess the anti-tumor effect, and further examine the safety and PK of ATX-295 at the RP2D.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists
        • Principal Investigator:
          • Judy Wang, MD
        • Contact:
          • Latisha Hall
          • Phone Number: 941-377-9993
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
        • Contact:
          • Latisha Hall
          • Phone Number: 615-329-7640
        • Principal Investigator:
          • Deepak Bhamidipati, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Timothy Yap, MD, PhD
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT Oncology
        • Principal Investigator:
          • Ildefonso Ismael Rodriguez Rivera, MD
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Next Virginia
        • Principal Investigator:
          • Alexander Spira, MD, PhD, FACP
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
Subjects will be enrolled at various doses and/or schedules of ATX-295 to identify the expansion dose(s) and RP2D
Drug: ATX-295
ATX-295 Tablets will be taken orally
Experimental: Dose Expansion: Platinum-Resistant, -Refractory, or -Intolerant HGSOC
Drug: ATX-295
ATX-295 Tablets will be taken orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of ATX-295
Time Frame: 12 months
Identification of a tolerable and safe dose for expansion cohorts based on dose limiting toxicities
12 months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: 12 months
Adverse events graded according to CTCAE v5.0
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary evidence of antitumor activity
Time Frame: 12 months
Objective response rate based on RECIST v1.1
12 months
Calculated time to reach maximum observed plasma concentration (Tmax)
Time Frame: 12 months
12 months
Measurement of phospho-histone H3 in pre- and post-treatment biopsies for a subset of participants (pharmacodynamic biomarker)
Time Frame: 12 months
12 months
Maximum observed plasma concentration of ATX-295 (Cmax)
Time Frame: 12 months
12 months
Calculated area under the plasma concentration-time curve of ATX-295 (AUC0-t)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Accent Therapeutics

Investigators

  • Study Director: Gozde Colak, PhD, 339-707-5855

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

January 18, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATX-295-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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