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

Launched by ACCENT THERAPEUTICS · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ATX-295, which is taken by mouth. The main goal is to find out the safest dose of this drug for patients with advanced solid tumors, including different types of cancer like ovarian cancer and triple-negative breast cancer. Researchers want to understand how the body processes the drug and whether it can help shrink tumors in patients who have already tried other treatments without success.

To participate in this trial, patients should have a confirmed diagnosis of advanced solid tumors that have come back or spread to other parts of the body. They must have already received standard treatments that didn’t work for them. The study is open to both men and women aged 65 and older. Participants will be closely monitored during the study and may experience some side effects, as with any treatment. It's important for potential participants to discuss this opportunity with their healthcare provider to see if it’s the right choice for them.

Gender

ALL

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