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DHX9 Inhibitor

ATX-559 for Cancer

Phase 1
Recruiting
Research Sponsored by Accent Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For the expansion cohorts, participants must have histological confirmation of the specified tumor types: BRCA1 or BRCA2 deficient, HER2 negative metastatic breast cancer with no limit to the number of prior treatment regimens; dMMR or MSI-H with unresectable or metastatic solid tumors with 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
Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease
Must not have
Clinically significant (ie, active) or uncontrolled cardiovascular disease
Clinically unstable central nervous system (CNS) tumors or brain metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find a safe dose of a new drug called ATX-559 that is taken by mouth. It will also look at how the drug is processed in the body, its effects on

Who is the study for?
This trial is for individuals with advanced or metastatic solid tumors, including colorectal, endometrial, breast, colon, and rectal cancers. Participants should have specific molecular markers that make them suitable for treatment with ATX-559.
What is being tested?
The study tests the safety and appropriate dosage of a new oral medication called ATX-559 designed to inhibit DHX9. It also looks at how the body processes the drug and its preliminary effects on shrinking or controlling tumor growth.
What are the potential side effects?
Since this is a first-in-human study for ATX-559, potential side effects are not yet fully known but may include typical reactions to cancer medications such as nausea, fatigue, diarrhea, and possible liver toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned or spread to other parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active or uncontrolled heart problems.
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I do not have unstable brain tumors or metastasis.
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I am not receiving any other cancer treatments.
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I cannot stop taking medication that affects my liver enzyme CYP2C8.
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I have a condition that affects my ability to swallow or absorb medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of ATX-559
Safety and tolerability of ATX-559
Secondary study objectives
Preliminary evidence of antitumor activity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dose escalationExperimental Treatment1 Intervention
Subjects will be enrolled at various doses or schedules of ATX-559 to identify the RP2D
Group II: Dose Expansion: MSI-H/dMMR solid tumorsExperimental Treatment1 Intervention
Group III: Dose Expansion: BRCA1- or BRCA2-deficient HER2-negative breast cancerExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Accent TherapeuticsLead Sponsor
~67 spots leftby Oct 2026
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