Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06799065 · ClinicalTrials.gov registry record · Phase 1

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 study of Ovarian Cancer and Advanced Solid Tumors, sponsored by Accent Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
90
Enrollment target
5
Study locations

NCT06799065: Recruiting Phase 1 study of Ovarian Cancer and Advanced Solid Tumors, sponsored by Accent Therapeutics.

NCT06799065 is a Phase 1 study of Ovarian Cancer and Advanced Solid Tumors that is actively recruiting participants, run by Accent Therapeutics. The registered enrollment target is 90 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (88% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06799065, a Phase 1 study of Ovarian Cancer and Advanced Solid Tumors, is actively recruiting participants, sponsored by Accent Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
90 participants
Enrollment target
5
Study locations

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 in patients with advanced solid tumors and ovarian cancer.

Primary Outcome

Identification of a tolerable and safe dose for expansion cohorts based on dose limiting toxicities

Interventions

  • DRUG ATX-295

Study Locations (5)

Texas

  • MD Anderson Cancer Center - Houston
  • NEXT Oncology - San Antonio

Florida

  • Florida Cancer Specialists - Sarasota

Tennessee

  • SCRI Oncology Partners - Nashville

Virginia

  • NEXT Virginia - Fairfax

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2025-03-21
Est. Completion 2027-08-30
Phase Phase 1
Accent Therapeutics

2 total trials

What NCT06799065 shows while recruiting

NCT06799065 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (88% lower).

The record links to 5 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which ATX-295 is the first listed.

NCT06799065 lists 5 locations in 4 states (Texas, Florida, Tennessee).

Frequently Asked Questions

What is clinical trial NCT06799065 about?

NCT06799065 is a clinical study titled "First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including 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.

What is the current status of trial NCT06799065?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2025-03-21. Estimated completion is 2027-08-30.

What conditions does trial NCT06799065 study?

This clinical trial studies the following conditions: Ovarian Cancer, Advanced Solid Tumors, Triple Negative Breast Cancer, Breast Cancer Recurrent, High-grade Serous Ovarian Carcinoma.

What interventions are being tested in trial NCT06799065?

The interventions under investigation include: ATX-295 (DRUG).

Who is sponsoring clinical trial NCT06799065?

This trial is sponsored by Accent Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06799065 being conducted?

This trial has 5 study locations across Florida, Tennessee, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Ovarian Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06799065's enrollment target sits among peer trials

90 156th of 322 higher than 162 of 322 other Ovarian Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02521311 · 90 participants · Phase 2

    Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)

  • NCT02939573 · 90 participants · Phase 2

    A Randomized Multicenter Study for Isolated Skin Vasculitis

  • NCT03128879 · 90 participants · Phase 2

    Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL

  • NCT03184038 · 90 participants · NA

    Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT06799065, the US trial registry maintained by the National Library of Medicine. NCT06799065 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.