# 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

Source: https://onco.cc/trials/nct06799065/  
OnCo record `nct06799065` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of ATX-295 run by Accent Therapeutics, now recruiting.

## Summary

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 is a phase 1/2 interventional study registered as NCT06799065 by Accent Therapeutics, with 218 participants planned, started 2025-03-21. Conditions recorded: Advanced Solid Tumors, Breast Cancer Recurrent, Ovarian Cancer, High-grade Serous Ovarian Carcinoma, Triple Negative Breast Cancer, sqNSCLC and Squamous Non-small-cell Lung Cancer. Interventions recorded: ATX-295 and ATX-295 and bevacizumab (or biosimilar).

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-11-03
- Tags: pipeline; ctgov-ingest
- Registry id: NCT06799065
- Phase: 1/2
- Setting: 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, as Monotherapy and in Combination With Anticancer Therapy in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer
- Sponsor: Accent Therapeutics
- Enrolled: 218

## Sources

- ClinicalTrials.gov NCT06799065: https://clinicaltrials.gov/study/NCT06799065

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- drugs: [ATX-295](https://onco.cc/drugs/atx-295/)
- companies: [Accent Therapeutics](https://onco.cc/companies/accent-therapeutics/)

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