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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Accent Therapeutics
Study ID
NCT06799065
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ATX-295 — DRUG
    ATX-295 Tablets will be taken orally

Study Details

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.

Key Dates

First listed
Jan 29, 2025
Start date
Mar 21, 2025
Status verified
Aug 2026
Primary completion
Apr 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Subjects will be enrolled at various doses and/or schedules of ATX-295 to identify the expansion dose(s) and RP2D
  • Experimental: Dose Expansion: Platinum-Resistant, -Refractory, or -Intolerant HGSOC

Primary Outcome Measure

Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of ATX-295 [ Time Frame: 12 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of Colorado DenverAuroraColorado80045
Michael Ehrmann
[email protected]
720-848-0300
Marisa Moroney, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer SpecialistsSarasotaFlorida34232
Latisha Hall
941-377-9993
Judy Wang, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201
Davonna Felder
[email protected]
313 576 9014
Wasif Saif, MD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Christina Caldwell
[email protected]
405-271-8001
Kathleen Moore, MD (PRINCIPAL_INVESTIGATOR)
NYU Grossman School of MedicineNew YorkNew York10016
NYU Langone Health Perlmutter Cancer Center Clinical Trials Office
[email protected]
212-263-4432
Bhavana Pothuri, MD (PRINCIPAL_INVESTIGATOR)
SCRI Oncology PartnersNashvilleTennessee37203
Latisha Hall
615-329-7640
Deepak Bhamidipati, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Timothy Yap, MD, PhD
[email protected]
(713) 563-1784
Timothy Yap, MD, PhD (PRINCIPAL_INVESTIGATOR)
NEXT OncologySan AntonioTexas78229
Jordan Georg
[email protected]
210-580-5921
Ildefonso Ismael Rodriguez Rivera, MD (PRINCIPAL_INVESTIGATOR)
NEXT VirginiaFairfaxVirginia22031
Maybelle De La Rosa
[email protected]
703-783-4518
Alexander Spira, MD, PhD, FACP (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado Denver· Aurora, COFlorida Cancer Specialists· Sarasota, FLKarmanos Cancer Institute· Detroit, MIUniversity of Nebraska Medical Center· Omaha, NENYU Grossman School of Medicine· New York, NYSCRI Oncology Partners· Nashville, TN

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