[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Antares Therapeutics, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"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":19,"type":20},343,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27],"Advanced Solid Tumors",[29,30,31],"locally advanced or metastatic solid tumors","(HR) positive (HR+) breast cancer","HER2 negative (HER2-) breast cancer","NOT_YET_RECRUITING","2026-08-11",{"date":35,"type":36},"2026-08-17","ACTUAL",{"date":38,"type":20},"2026-08-01",{"date":40,"type":20},"2030-01-31",{"name":42,"class":43},"Antares Therapeutics, Inc","INDUSTRY",""]