First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer
NCT ID: NCT06799065
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
90 participants
INTERVENTIONAL
2025-03-21
2027-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Subjects will be enrolled at various doses and/or schedules of ATX-295 to identify the expansion dose(s) and RP2D
ATX-295
ATX-295 Tablets will be taken orally
Dose Expansion: Platinum-Resistant, -Refractory, or -Intolerant HGSOC
ATX-295
ATX-295 Tablets will be taken orally
Interventions
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ATX-295
ATX-295 Tablets will be taken orally
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Accent Therapeutics
INDUSTRY
Responsible Party
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Locations
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Florida Cancer Specialists
Sarasota, Florida, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Latisha Hall
Role: primary
Latisha Hall
Role: primary
Other Identifiers
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ATX-295-001
Identifier Type: -
Identifier Source: org_study_id
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