RecruitingPhase 1NCT06799065

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

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


Sponsor

Accent Therapeutics

Enrollment

90 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

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 in patients with advanced solid tumors and ovarian cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study of ATX-295, a new oral (taken by mouth) drug that blocks a protein called KIF18A — a protein that cancer cells rely on to divide. It is being tested in patients with advanced or metastatic solid tumors, with a particular focus on ovarian cancer, including platinum-resistant high-grade serous ovarian cancer (HGSOC). **You may be eligible if...** - You have been diagnosed with a solid tumor (such as ovarian cancer) that is advanced or has spread - You have tried all standard available treatments, or your doctor believes standard treatment is not appropriate for you - For the ovarian cancer expansion cohort: you must have high-grade serous ovarian cancer that is platinum-resistant, platinum-refractory, or platinum-intolerant - You have measurable or evaluable disease on imaging - You are in adequate health (ECOG performance status meeting criteria) **You may NOT be eligible if...** - You have never tried standard treatments and are a suitable candidate for them - Your organ function does not meet the required thresholds - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGATX-295

ATX-295 Tablets will be taken orally


Locations(5)

Florida Cancer Specialists

Sarasota, Florida, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06799065


Related Trials