Actively Recruiting
First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer
Led by Accent Therapeutics · Updated on 2026-02-24
90
Participants Needed
5
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed locally recurrent or metastatic solid tumors, including high-grade serous ovarian carcinoma
- Cancer refractory to or relapsed after all standard therapies with proven benefit, or patients not candidates for or refusing standard treatments after understanding options
- For expansion cohorts, patients must have confirmed high-grade serous ovarian cancer that is platinum-resistant, platinum-refractory, or platinum-intolerant
- No limit on number of prior treatment regimens
- Measurable or evaluable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
You will not qualify if you...
- Clinically unstable central nervous system tumors or brain metastases
- Concurrent anti-cancer treatments except hormonal blockade
- Major surgery within 3 weeks before starting study treatment
- Medical conditions limiting oral intake or gastrointestinal function expected to reduce absorption of ATX-295, except functioning distal ileostomy or colostomy
- Active or uncontrolled cardiovascular disease
- Need to use proton pump inhibitors or H2-receptor antagonists during dose escalation phase
- Inability to stop strong or moderate CYP3A4 inhibitors or strong inducers
- Pregnancy or plans to breastfeed or conceive during treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
2
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
5
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
P
Priya Rajaratnam
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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