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NCT06799065 | NOT YET RECRUITING | Advanced Solid Tumors

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

Accent Therapeutics

Brief 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.

Condition or disease

Advanced Solid Tumors

Breast Cancer Recurrent

Ovarian Cancer

High-grade Serous Ovarian Carcinoma

Triple Negative Breast Cancer

Intervention/treatment

ATX-295

Phase

PHASE1

Detailed Description:

ATX-295 is an oral drug that inhibits a protein called KIF18A, an adenosine triphosphate (ATP)-dependent, plus end-directed mitotic kinesin. KIF18A facilitates chromosomal alignment and spindle microtubule dynamics during mitosis in certain advanced solid tumors. ATX-295 has been shown preclinically to induce robust anti-tumor activity of a variety of different solid tumors, including high-grade serious ovarian cancer and triple negative breast cancer. This is a first-in-human, Phase 1, open-label, single-arm, dose-escalation and Simon 2-Stage expansion study to evaluate the safety profile of ATX-295 and determine the recommended phase 2 dose (RP2D). In addition, the study aims to characterize the PK, PD, and preliminary anti-tumor activity of orally administered ATX-295. Exploratory objectives include examination of biomarker responses in relationship to ATX-295 exposure. Patients with locally advanced or metastatic solid tumors will be enrolled to preliminarily assess the anti-tumor effect, and further examine the safety and PK of ATX-295 at the RP2D.

Study Type : INTERVENTIONAL
Estimated Enrollment : 65 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-04-30
Estimated Primary Completion Date : 2027-04-30
Estimated Study Completion Date : 2027-08-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer

Location Details

NCT06799065

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