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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors

Sponsor: Antares Therapeutics, Inc • ClinicalTrials.gov ID: NCT07767474

Registry updated: 2026-10-16
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Description

Study ATX-898-101 is a phase 1/2 open-label study evaluating the safety, tolerability, pharmacokinetic, and preliminary efficacy of ATX-898 as monotherapy and in combination with anti-neoplastic agents in selected solid tumors. This study consists of 2 parts. Part 1 evaluates ATX-898 as monotherapy and Part 2 evaluates ATX-898 in combination with anti-neoplastic agents of interest. Both parts will consists of a dose escalation portion and a dose expansion portion.

Interventions

  • ATX-898 (Drug)
    Doses defined per protocol
  • ATX-898 (Drug)
    RDE
  • ATX-898 (Drug)
    RDE
  • ATX-898 (Drug)
    RDE
  • ATX-898 (Drug)
    Doses defined per protocol
  • ATX-898, fulvestrant, ribociclib (Drug)
    ATX-898 at RDE, Fulvestrant and abemaciclib: doses defined per protocol
  • ATX-898, fulvestrant, ribociclib (Drug)
    ATX-898 at RDE, Fulvestrant and abemaciclib: doses defined per protocol
  • ATX-898, fulvestrant, ribociclib (Drug)
    Doses defined per protocol

Eligibility criteria

Inclusion Criteria: * Has histologically or cytologically confirmed advanced solid tumor malignancy that is metastatic or locally advanced and unresectable * Is ≥18 years of age at the time of signing the informed consent form * ECOG performance status score of 0 or 1 * Adequate organ function * Must consent to a pre-treatment tumor biopsy (collected during screening or have available archival tumor tissue in the past 5 years. For Part 1a (monotherapy dose escalation) * Has received one or more standard systemic therapies and additional standard therapies are either not available, or participant ineligible for available standard therapies For Part 1b (monotherapy dose expansion) * b1: Has platinum-resistant or refractory metastatic ovarian cancer * b2: Has recurrent or metastatic gynecologic cancer excluding the cancers eligible for b1 * b3: Has recurrent advanced or metastatic solid tumor excluding the cancers eligible for b1 or b2 * Has at least 1 measurable lesion per RECIST 1.1 For Part 2a (combination dose escalation) * Has confirmed HR+ HER2 - (including HER2 low and ultra low) status * Has received prior therapy in the metastatic For Part 2b (combination dose expansion) * Has confirmed HR+ HER2 - (including HER2 low and ultra low) status * Treatment-naïve or has received prior therapy in the metastatic setting Exclusion Criteria: * Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancer being studied * Has symptomatic CNS metastases at screening or asymptomatic CNS metastases requiring corticosteroids to control symptoms within 28 days prior to the first dose of ATX-898. * Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, with the exception of alopecia any grade and Grade ≤2 peripheral neuropathy * Has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant or would prevent, limit, or confound the protocol-specified assessments Cohort Specific: * For abemaciclib cohorts only: has a history of any events of cardiac etiology that would contraindicate dosing with abemaciclib * For ribocicilib only: has history of pneumonitis or interstitial lung disease

Conditions

Advanced Solid Tumors

Locations

  • START Dallas Fort Worth Cancer Center — Fort Worth, Texas, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • START San Antonio Cancer Center — San Antonio, Texas, United States
  • START Mountain Region Cancer Center — West Valley City, Utah, United States
  • NEXT Virginia Cancer Center- Merrifield Tech Center — Fairfax, Virginia, United States
  • Linear Clinical Research — Perth, Western Australia, Australia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record