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 1/2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-295, an Oral Inhibitor of the Kinesin Motor Protein KIF18A, in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer
Accent Therapeutics
90 participants
Mar 21, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria8
- 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
Interventions
ATX-295 Tablets will be taken orally
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06799065