RECRUITING

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

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Conditions

Advanced Solid TumorsBreast Cancer RecurrentOvarian CancerHigh-grade Serous Ovarian CarcinomaTriple Negative Breast CancerKIFKIF18AHGSOCPlatinum-resistantPlatinum-intolerantPlatinum-refractory

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-21
Study Completion:2027-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06799065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease, including HGSOC
  2. * 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
  3. * For the expansion cohorts, participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, platinum-refractory, or platinum-intolerant
  4. * There is no limit to the number of prior treatment regimens
  5. * Have measurable or evaluable disease
  6. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  1. * Clinically unstable central nervous system (CNS) tumors or brain metastasis
  2. * Any other concurrent anti-cancer treatment, except for hormonal blockade
  3. * Has undergone a major surgery within 3 weeks of starting study treatment
  4. * 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
  5. * Clinically significant (ie, active) or uncontrolled cardiovascular disease
  6. * Need to use proton pump inhibitors on study or H2-receptor antagonists for the dose escalation portion of the study.
  7. * Unable to transition off strong or moderate CYP3A4 inhibitors or strong inducers
  8. * Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment

Contacts and Locations

Study Contact

Jason Sager
CONTACT
(339) 970-7400
clinicaltrials@accenttx.com
Melinda Snyder
CONTACT
(617) 233-4057
clinicaltrials@accenttx.com

Study Locations (Sites)

NEXT Oncology
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Accent Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-21
Study Completion Date2027-08-30

Study Record Updates

Study Start Date2025-03-21
Study Completion Date2027-08-30

Terms related to this study

Keywords Provided by Researchers

  • KIF
  • KIF18A
  • HGSOC
  • Platinum-resistant
  • Platinum-intolerant
  • Platinum-refractory

Additional Relevant MeSH Terms

  • Advanced Solid Tumors
  • Breast Cancer Recurrent
  • Ovarian Cancer
  • High-grade Serous Ovarian Carcinoma
  • Triple Negative Breast Cancer