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

NCT06799065

RecruitingPhase 1

Sponsor: Accent Therapeutics

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

Interventions: ATX-295

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 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

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

Locations (9)

Aurora, Colorado, United States
Sarasota, Florida, United States
Detroit, Michigan, United States
Omaha, Nebraska, United States
New York, New York, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States