First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, as Monotherapy and in Combination With Anticancer Therapy in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer

StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 2 changed
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Record History

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  1. Re-verified, no change to tracked fields
  2. Study sites: 10 to 11
  3. Primary endpoint(s) modified Show 9 more changesShow less
    • Phase changed: Phase 1 → Phase 1/2
    • Enrollment increased: 90 → 218 participants
    • Interventions modified
    • Trial arms changed: 2 → 4
    • Study sites: 9 to 10
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 35 words
    • Study title expanded, about 8 words
  4. Primary endpoints: details revised at 1 of 2 entries
    • Eligibility criteria expanded, about 14 words
    • Study sites revised (9)
  5. Trial sites expanded: 6 → 9 locationsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 5 to 6v9
  2. Re-verified, no change to tracked fieldsv8
  3. Study sites: 4 to 5v7
  4. Enrollment target: 65 to 90v6
  5. Re-verified, no change to tracked fieldsv5
  6. Study sites: 2 to 4v4
  7. Study sites: 1 to 2v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 30, 2025 to Mar 21, 2025
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Accent Therapeutics
2 trials monitored
See 1 trial at risk
Breast Cancer
5,466 trials monitored
See 312 trials at risk
Lung Cancer
4,803 trials monitored
See 272 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,087 trials monitored
See 179 trials at risk
and 2 more diseases
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 as a monotherapy and in combination with bevacizumab (or a biosimilar) in patients with locally advanced or metastatic solid tumors, including ovarian cancer and lung cancer.
Trial Details
NCT Number NCT06799065
Lead Sponsor Accent Therapeutics
Conditions
(from sponsor)		 Advanced Solid Tumors, Breast Cancer Recurrent, Ovarian Cancer, High-grade Serous Ovarian Carcinoma, Triple Negative Breast Cancer, sqNSCLC, Squamous Non-small-cell Lung Cancer
Related terms Ovarian Neoplasms, Triple Negative Breast Neoplasms
Enrollment 218 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov