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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

San Antonio

NEXT Oncology, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Accent Therapeutics,

Study Record Dates

2027-02