First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer
NCT06799065 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-02-24
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.
Conditions
- Advanced Solid Tumors
- Breast Cancer Recurrent
- Ovarian Cancer
- High-grade Serous Ovarian Carcinoma
- Triple Negative Breast Cancer
Interventions
- DRUG
-
ATX-295
ATX-295 Tablets will be taken orally
Sponsors & Collaborators
-
Accent Therapeutics
lead INDUSTRY
Principal Investigators
-
Gozde Colak, PhD · 339-707-5855
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-21
- Primary Completion
- 2027-04-30
- Completion
- 2027-08-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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