ATX-559 for Cancer

Recruiting at 6 trial locations

Overseen By Melinda Snyder

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Accent Therapeutics

Must not be taking: CYP2C8 inhibitors, CYP2C8 inducers

Disqualifiers: CNS tumors, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking any other anti-cancer treatments and transition off strong or moderate CYP2C8 inhibitors or inducers (types of medications that affect how drugs are processed in the body).

Eligibility Criteria

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.

Inclusion Criteria

My cancer has returned or spread to other parts of my body.

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

My condition did not improve after all standard treatments, or I cannot receive or refused them.

Exclusion Criteria

I am not receiving any other cancer treatments.

I do not have active or uncontrolled heart problems.

I do not have unstable brain tumors or metastasis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Subjects will be enrolled at various doses or schedules of ATX-559 to identify the recommended phase 2 dose (RP2D)

12 months

Dose Expansion

Participants with MSI-H/dMMR solid tumors and BRCA1- or BRCA2-deficient HER2-negative breast cancer will be enrolled to assess anti-tumor effect and further examine safety and PK of ATX-559 at the RP2D

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ATX-559

Trial Overview 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.

Participant Groups

Group I: Dose escalation Experimental Treatment 1 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 tumors Experimental Treatment 1 Intervention

Group III: Dose Expansion: BRCA1- or BRCA2-deficient HER2-negative breast cancer Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Accent Therapeutics

Lead Sponsor

Trials

2

Recruited

170+