NCT06625515TerminatedPhase 1
First-in-Human Study of ATX-559, an Oral Inhibitor of DHX9, in Patients With Advanced or Metastatic Solid Tumors, and Molecularly Defined Cancers
A Phase 1/2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-559, an Oral Inhibitor of the Helicase DHX9, in Patients With Locally Advanced or Metastatic Solid Tumors and Molecularly Defined Cancers
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Reason given: The study was terminated by sponsor based on the adverse event profile.
Brief summary (registry, in English)
The goal of this study is to identify a safe and tolerated dose of the orally administered DHX9 inhibitor ATX-559. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ATX-559 in patients with advanced solid tumors and molecularly defined cancers.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 23 Sept 2024
- Start date
- 11 Oct 2024
- Primary completion date
- 9 Jan 2026
- Lead sponsor
- Accent Therapeutics
- Diseases
- Colorectal cancer, Endometrial cancer
- NCT number
- NCT06625515
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any other concurrent anti-cancer treatment
- Has undergone a major surgery within 3 weeks of starting study treatment
- Unable to transition off strong or moderate CYP2C8 inhibitors or inducers
Other illness
- Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-559
- Clinically significant (ie, active) or uncontrolled cardiovascular disease
Other
- Clinically unstable central nervous system (CNS) tumors or brain metastasis
- 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
Who the study is looking for
- Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease
- 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 the specified tumor types:
- BRCA1 or BRCA2 deficient, HER2 negative metastatic breast cancer
- dMMR or MSI-H with unresectable or metastatic solid tumors
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Cancer Center - Anschutz Medical Campus | Aurora | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center | Houston | United States | Unknown status |
| SCRI Oncology Partners | Nashville | United States | Unknown status |
| Stephenson Cancer Center at OU Medicine | Oklahoma City | United States | Unknown status |
| NEXT Oncology | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.