Back to search results

First-in-Human Study of ATX-295 for Advanced Solid Tumors and Ovarian Cancer

This study is testing a new oral medication called ATX-295. It's designed for people with advanced or metastatic (spread) solid tumors, including ovarian cancer and triple-negative breast cancer, who have already tried standard treatments. ATX-295 works by blocking a protein called KIF18A, which helps cancer cells grow. The main goals are to find a safe and tolerable dose of ATX-295 and to see how well it's tolerated. Researchers will also look at how the drug moves through the body and if it shows any early signs of shrinking tumors. The study plans to enroll about 90 participants.

Study design
This is a Phase 1 study, meaning it's the first time this drug is being tested in humans. It's an open-label study, so you and your doctors will know you are receiving ATX-295. The study will enroll about 90 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure safety and tolerability for 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06799065

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Accent Therapeutics
~90 participants
Updated 2026-09-16 on ClinicalTrials.gov
What's tested:ATX-295

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of ATX-295
Measured over 12 months
+1 more outcome measured

Conditions

Advanced Solid Tumors
Breast Cancer Recurrent
Ovarian Cancer
High-grade Serous Ovarian Carcinoma
Triple Negative Breast Cancer

Explore related trials

Ovarian High Grade Serous AdenocarcinomaSolid NeoplasmTriple-negative breast cancer

NCT06799065

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Florida Cancer Specialists

    Sarasota, Floridastudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • NEXT Oncology

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • NEXT Virginia

    Fairfax, Virginiastudy coordinator listed

    Recruiting

  • NYU Longone Health

    New York, New Yorkstudy coordinator listed

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennesseestudy coordinator listed

    Recruiting

  • University of Colorado Denver

    Aurora, Coloradostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Gozde Colak, PhD · STUDY_DIRECTOR · 339-707-5855

Who to contact

Priya Rajaratnam
[email protected]
339) 970-7383
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of ATX-29512 months

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

  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)12 months

    Adverse events graded according to CTCAE v5.0