Study on ATX-898 for Adults with Advanced Solid Tumors

Sponsor: Antares Therapeutics, Inc

Sponsor score: 0

ClinicalTrials ID:NCT07767474

This clinical trial is testing a new drug, ATX-898, to see if it is safe and effective for treating advanced solid tumors. The study will look at ATX-898 alone and in combination with other cancer treatments.

Patient Parameters

Program Overview

The study is divided into two parts. Part 1 tests ATX-898 by itself to find the best dose and see how well it works. Part 2 tests ATX-898 combined with other cancer drugs to see if the combination is safe and effective. Both parts will start with finding the right dose and then expand to include more participants.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced solid tumor that cannot be surgically removed and has spread.
  • Be 18 years or older.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have good organ function based on medical tests.
  • Agree to provide a tumor sample before starting treatment.

For Part 1a (testing ATX-898 alone):

  • Have tried at least one standard cancer treatment, and no other standard treatments are available or suitable.

For Part 1b (expanding ATX-898 alone):

  • b1: Have ovarian cancer that does not respond to platinum-based treatments.
  • b2: Have recurrent or metastatic gynecologic cancer, excluding those in b1.
  • b3: Have recurrent advanced or metastatic solid tumor, excluding those in b1 or b2.
  • Have at least one measurable tumor.

For Part 2a (testing ATX-898 with other drugs):

  • Have hormone receptor-positive, HER2-negative cancer (including low and ultra-low HER2 levels).
  • Have received prior treatment for metastatic cancer.

For Part 2b (expanding ATX-898 with other drugs):

  • Have hormone receptor-positive, HER2-negative cancer (including low and ultra-low HER2 levels).
  • Either have not been treated or have received prior treatment for metastatic cancer.

Exclusion Criteria

  • Have had a different type of cancer within the last 2 years.
  • Have cancer that has spread to the brain and is causing symptoms or requires steroids to manage symptoms.
  • Have side effects from previous cancer treatments that have not improved, except for hair loss or mild nerve damage.
  • Have any condition that the study doctor believes would make participation unsafe or interfere with the study.

Cohort Specific:

  • For those taking abemaciclib: Have a history of heart problems that would prevent taking abemaciclib.
  • For those taking ribociclib: Have a history of lung inflammation or lung disease.

Locations

FACILITYZIPCITYSTATE
START Dallas Fort Worth Cancer Center76104Fort WorthTexas
MD Anderson Cancer Center77030HoustonTexas
START San Antonio Cancer Center78229San AntonioTexas
START Mountain Region Cancer Center84119West Valley CityUtah
NEXT Virginia Cancer Center- Merrifield Tech Center22031FairfaxVirginia

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