Testing ATX-295 for advanced solid tumors and ovarian cancer
Official title: 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
Run by Accent Therapeutics · NCT06799065 · Data updated 2026-11-12
This study is testing a new oral medication called ATX-295 to see if it is safe and effective for people with advanced solid tumors, including ovarian cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 218 (estimated) |
| Sponsor | Accent Therapeutics Industry-sponsored |
| Drugs / interventions | bevacizumab |
| Locations | 11 sites (Aurora, Colorado and 10 other locations) |
| Status | Recruiting |
| Started | March 21, 2025 |
| Main results expected | April 30, 2027 |
| Study ends | August 30, 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT06799065 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with histologically confirmed advanced solid tumors, particularly those who are platinum-resistant or have high-grade serous ovarian carcinoma.
✕Probably not a fit
Patients with clinically unstable central nervous system tumors or those receiving concurrent anti-cancer treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and tolerability of ATX-295, an oral inhibitor of KIF18A, in patients with advanced solid tumors, including ovarian cancer. It is a first-in-human, Phase 1, open-label, single-arm, dose-escalation study aimed at determining the recommended phase 2 dose (RP2D) while assessing pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity. Patients with locally advanced or metastatic solid tumors will be enrolled to examine the drug's effects and safety profile. The study also explores biomarker responses related to ATX-295 exposure.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors and ovarian cancer who have limited treatment alternatives.
How similar studies have gone: While this approach is novel in humans, preclinical studies have shown promising anti-tumor activity of ATX-295 in various solid tumors.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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 monotherapy expansion cohorts: * Participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, or platinum-intolerant * Participants with sqNSCLC should have received prior treatment with a platinum, taxane, and checkpoint inhibitor * For the combination with bevacizumab (or biosimilar): Participants must have histologically confirmed HGSOC or select solid tumors * There is no limit to the number of prior treatment regimens * Have measurable disease; evaluable disease is acceptable during dose escalation * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Key Exclusion Criteria: * 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 Other inclusion and exclusion criteria as defined in the study protocol
Where it's running
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University of Colorado Denver
Aurora, Colorado, United States Recruiting -
Florida Cancer Specialists
Sarasota, Florida, United States Recruiting -
Karmanos Cancer Institute
Detroit, Michigan, United States Recruiting -
Washington University
St Louis, Missouri, United States Recruiting -
University of Nebraska Medical Center
Omaha, Nebraska, United States Recruiting -
NYU Longone Health (Long Island)
Long Island City, New York, United States Recruiting
Show 5 more locations
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NYU Longone Health (Manhattan)
Manhattan, New York, United States Recruiting -
SCRI Oncology Partners
Nashville, Tennessee, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
NEXT Oncology
San Antonio, Texas, United States Recruiting -
NEXT Virginia
Fairfax, Virginia, United States Recruiting
Study contacts
- Study coordinator: Priya Rajaratnam
- Email: clinicaltrials@accenttx.com
- Phone: (339) 970-7383
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.