Clinical trialNCT06799065RecruitingPhase 1Interventional

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

SponsorAccent TherapeuticsEnrollment90Advanced Solid TumorsBreast Cancer RecurrentHigh-grade Serous Ovarian CarcinomaOvarian CancerTriple Negative Breast Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Gozde Colak, PhD
339-707-5855
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Colorado Denver
Aurora, Colorado, United States
Marisa Moroney, MD
Recruiting
Florida Cancer Specialists
Sarasota, Florida, United States
Judy Wang, MD
Recruiting
Karmanos Cancer Institute
Detroit, Michigan, United States
Wasif Saif, MD
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, United States
Kathleen Moore, MD
Recruiting
Nyu Grossman School of Medicine
New York, New York, United States
Bhavana Pothuri, MD
Recruiting
Scri Oncology Partners
Nashville, Tennessee, United States
Deepak Bhamidipati, MD
Recruiting
Md Anderson Cancer Center
Houston, Texas, United States
Timothy Yap, MD, PhD
Recruiting
Next Oncology
San Antonio, Texas, United States
Ildefonso Ismael Rodriguez Rivera, MD
Recruiting
Next Virginia
Fairfax, Virginia, United States
Alexander Spira, MD, PhD, FACP
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ATX-295 →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 21 Mar 2025
Primary completion: 30 Apr 2027
Completion: 30 Aug 2027
Last update posted: 18 Aug 2026
Registered enrollment: 90
Registry id: NCT06799065

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.