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A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors
First-in-human Study of ATX-898, as Monotherapy and in Combination With Other Anti-neoplastic Agents, in Participants With Advanced Solid Tumors
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- ATX-898 (drug)
- ATX-898 (drug)
- ATX-898 (drug)
- ATX-898 (drug)
- ATX-898 (drug)
- ATX-898, fulvestrant, ribociclib (drug)
Sponsor: Antares Therapeutics, Inc · Participants: 343 · Started: Aug 31, 2026
Contact the study team
- Antares Medical Monitor · Phone: +1 781-288-5760
Official record on ClinicalTrials.gov — NCT07767474
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.