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

Launched by ACCENT THERAPEUTICS · Oct 1, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new oral medication called ATX-559, which aims to treat patients with advanced solid tumors, including certain types of breast, colorectal, and endometrial cancers. The main goal of the study is to find out a safe dose of ATX-559 and see how well it works in fighting these cancers. The trial is currently recruiting participants aged 65 and older who have solid tumors that have either come back after treatment or have spread to other parts of the body. To qualify, patients must have tumors that are not responding to standard treatments or have already tried all available options.

Participants in this trial can expect to take the medication orally and will be closely monitored by researchers throughout the study. They will assess how the medicine works in the body and check for any side effects. It’s important to note that individuals with certain health conditions, such as unstable brain tumors or those currently receiving other cancer treatments, may not be eligible to join. Overall, this trial represents an important step in exploring new treatment options for patients with challenging cancer diagnoses.

Gender

ALL

Eligibility criteria

• Key Inclusion 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
• Key Exclusion Criteria:
• • 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
• • Other inclusion and exclusion criteria as defined in the study protocol