TERMINATED

First-in-Human Study of ATX-559, an Oral Inhibitor of DHX9, in Patients With Advanced or Metastatic Solid Tumors, and Molecularly Defined Cancers

Conditions

Advanced Solid Tumors Breast Cancer Recurrent Colorectal Cancer Metastatic Colon Cancer Rectal Adenocarcinoma Endometrial Cancer MSI-high/dMMR tumors BRCA1 mutation BRCA2 mutation DHX9 dMMR deficient mismatch repair microsatellite instability

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-11

Study Completion:2026-01-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06625515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* Clinically unstable central nervous system (CNS) tumors or brain metastasis * Any other concurrent anti-cancer treatment * 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-559 * Clinically significant (ie, active) or uncontrolled cardiovascular disease * Unable to transition off strong or moderate CYP2C8 inhibitors or inducers * Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment

Inclusion Criteria

Exclusion Criteria

* 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

* Clinically unstable central nervous system (CNS) tumors or brain metastasis
* Any other concurrent anti-cancer treatment
* 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-559
* Clinically significant (ie, active) or uncontrolled cardiovascular disease
* Unable to transition off strong or moderate CYP2C8 inhibitors or inducers
* Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment

Contacts and Locations

Study Locations (Sites)

University of Colorado Cancer Center - Anschutz Medical Campus,

Aurora, Colorado, 80045

United States

Stephenson Cancer Center at OU Medicine

Oklahoma City, Oklahoma, 73104

United States

SCRI Oncology Partners

Nashville, Tennessee, 37203

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

NEXT Oncology

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Accent Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-11

Study Completion Date2026-01-09

Study Record Updates

Study Start Date2024-10-11

Study Completion Date2026-01-09

Terms related to this study

Keywords Provided by Researchers

MSI-high/dMMR tumors
BRCA1 mutation
BRCA2 mutation
DHX9
dMMR
deficient mismatch repair
microsatellite instability

Additional Relevant MeSH Terms

Advanced Solid Tumors
Breast Cancer Recurrent
Colorectal Cancer Metastatic
Colon Cancer
Rectal Adenocarcinoma
Endometrial Cancer