[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652073":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":49,"centralContacts":67,"locations":49,"responsibleParty":73,"collaborators":49,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":49,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":49,"enrollmentInfo":84,"targetDuration":49,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":98,"whyStopped":49,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":49},{"fullName":5,"class":6},"Antares Therapeutics, Inc","INDUSTRY",[8,14,18,22,26,30,35,39],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1a: Monotherapy Dose Escalation","EXPERIMENTAL","ATX-898 will be given at a protocol defined starting dose for the treatment of participants with selected advanced or metastatic solid tumors.\n\nSubsequent dose regimen will be determined during study execution",[13],"Drug: ATX-898",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1b1: Monotherapy Dose Expansion Cohort Disease Group 1","ATX-898 will be given at the recommended dose for expansion (RDE) for the treatment of participants with selected advanced or metastatic ovarian cancer",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 1b2: Monotherapy Dose Expansion Cohort Disease Group 2","ATX-898 will be given at the recommended dose for expansion (RDE) for the treatment of participants with selected advanced or metastatic gynecologic cancers other than ovarian cancers",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part 1b2: Monotherapy Dose Expansion Cohort Disease Group 3","ATX-898 will be given at the recommended dose for expansion (RDE) for the treatment of participants with selected advanced or metastatic solid tumors other than gynecologic cancers",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Part 2a 1: Combination Dose Escalation","ATX-898 will be given at a recommended starting dose in combination with fulvestrant and abemaciclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer. Subsequent dose regimen of ATX-898 will be determined during study execution",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Part 2b 1: Combination Dose Expansion","ATX-898 will be given at a recommended dose for expansion (RDE) in combination with fulvestrant and abemaciclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer",[34],"Drug: ATX-898, fulvestrant, ribociclib",{"label":36,"type":10,"description":37,"interventionNames":38},"Part 2b 2: Combination Dose Expansion","ATX-898 will be given at a recommended dose for expansion (RDE) in combination with fulvestrant and ribociclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer",[34],{"label":40,"type":10,"description":41,"interventionNames":42},"Part 2a 2: Combination Dose Escalation","ATX-898 will be given at a recommended starting dose in combination with fulvestrant and ribociclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer Subsequent dose regimen of ATX-898 will be determined during study execution",[34],[44,50,53,55,57,59,63,65],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","ATX-898","Doses defined per protocol",[9],null,{"type":45,"name":46,"description":51,"armGroupLabels":52,"otherNames":49},"RDE",[15],{"type":45,"name":46,"description":51,"armGroupLabels":54,"otherNames":49},[19],{"type":45,"name":46,"description":51,"armGroupLabels":56,"otherNames":49},[23],{"type":45,"name":46,"description":47,"armGroupLabels":58,"otherNames":49},[27],{"type":45,"name":60,"description":61,"armGroupLabels":62,"otherNames":49},"ATX-898, fulvestrant, ribociclib","ATX-898 at RDE, Fulvestrant and abemaciclib: doses defined per protocol",[31],{"type":45,"name":60,"description":61,"armGroupLabels":64,"otherNames":49},[36],{"type":45,"name":60,"description":47,"armGroupLabels":66,"otherNames":49},[40],[68],{"name":69,"role":70,"phone":71,"phoneExt":49,"email":72},"For questions concerning enrollment","CONTACT","000-000-0000","clinicaltrials@antaresrx.com",{"type":74,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100652073","phase-1-a-study-to-evaluate-atx-898-in-participants-with-advanced-solid-tumors-100652073",false,"NCT07767474","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","Inclusion Criteria:\n\n* Has histologically or cytologically confirmed advanced solid tumor malignancy that is metastatic or locally advanced and unresectable\n* Is ≥18 years of age at the time of signing the informed consent form\n* ECOG performance status score of 0 or 1\n* Adequate organ function\n* Must consent to a pre-treatment tumor biopsy (collected during screening or have available archival tumor tissue in the past 5 years.\n\nFor Part 1a (monotherapy dose escalation)\n\n* 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)\n* b1: Has platinum-resistant or refractory metastatic ovarian cancer\n* b2: Has recurrent or metastatic gynecologic cancer excluding the cancers eligible for b1\n* b3: Has recurrent advanced or metastatic solid tumor excluding the cancers eligible for b1 or b2\n* Has at least 1 measurable lesion per RECIST 1.1\n\nFor Part 2a (combination dose escalation)\n\n* Has confirmed HR+ HER2 - (including HER2 low and ultra low) status\n* Has received prior therapy in the metastatic For Part 2b (combination dose expansion)\n* Has confirmed HR+ HER2 - (including HER2 low and ultra low) status\n* Treatment-naïve or has received prior therapy in the metastatic setting\n\nExclusion Criteria:\n\n* Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancer being studied\n* 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.\n* 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\n* 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\n\nCohort Specific:\n\n* For abemaciclib cohorts only: has a history of any events of cardiac etiology that would contraindicate dosing with abemaciclib\n* For ribocicilib only: has history of pneumonitis or interstitial lung disease","ALL","18 Years",{"count":85,"type":86},343,"ESTIMATED","INTERVENTIONAL",[89,90],"PHASE1","PHASE2","Study ATX-898-101 is a phase 1\u002F2 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.",[93],"Advanced Solid Tumors",[95,96,97],"locally advanced or metastatic solid tumors","(HR) positive (HR+) breast cancer","HER2 negative (HER2-) breast cancer","NOT_YET_RECRUITING","2026-08-11",{"date":101,"type":102},"2026-08-17","ACTUAL",{"date":104,"type":86},"2026-08-01",{"date":106,"type":86},"2030-01-31",{"name":5,"class":6}]