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Breast Cancer Recurrent / ATX-295 / Advanced Solid Tumors · Phase 1 Trial
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record for an ongoing first-in-human Phase 1 study of ATX-295, a KIF18A inhibitor, in patients with advanced solid tumors and ovarian cancer. No results have been posted; the study is recruiting and designed to establish a safe and tolerated dose with evaluation of pharmacokinetics, pharmacodynamics, and preliminary antitumor activity over 12 months.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Advanced Solid Tumors, Breast Cancer Recurrent, Ovarian Cancer, High-grade Serous Ovarian Carcinoma, Triple Negative Breast Cancer; age from 18 Years. Intervention: Dose Escalation; Dose Expansion: Platinum-Resistant, -Refractory, or -Intole…. n = 90. 9 sites: United States.
This is a clinical trial registry record for an ongoing first-in-human Phase 1 study of ATX-295, a KIF18A inhibitor, in patients with advanced solid tumors and ovarian cancer. No results have been posted; the study is recruiting and designed to establish a safe and tolerated dose with evaluation of pharmacokinetics, pharmacodynamics, and preliminary antitumor activity over 12 months.
No safety, tolerability, pharmacokinetic, pharmacodynamic, or antitumor activity data are reported. Primary endpoints are dose-finding and safety; efficacy is not a primary outcome.
This study is not yet providing clinical evidence. Clinicians should await Phase 1 completion and dose recommendation before considering ATX-295 in clinical practice; preliminary antitumor activity will be exploratory only.
First-in-human Phase 1 dose-escalation study with no results posted; designed to establish safety, tolerability, and dose recommendations rather than efficacy.
As stated by the source record.
Quoted from the source exactly as published.
This study is not yet providing clinical evidence. Clinicians should await Phase 1 completion and dose recommendation before considering ATX-295 in clinical practice; preliminary antitumor activity will be exploratory only.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06799065). This is a study registration, not published results. Lead sponsor: Accent Therapeutics. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 90 participants (ESTIMATED). Conditions: Advanced Solid Tumors, Breast Cancer Recurrent, Ovarian Cancer, High-grade Serous Ovarian Carcinoma, Triple Negative Breast Cancer. Interventions: DRUG: ATX-295. Primary outcome measures: Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of ATX-295 , 12 months; Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) , 12 months. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.