[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567357":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":63,"studyPopulation":55,"armGroups":64,"interventions":74,"overallOfficials":55,"centralContacts":80,"locations":88,"responsibleParty":316,"collaborators":55,"id":318,"slug":55,"hasResults":319,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":55,"eligibilityCriteria":323,"healthyVolunteers":319,"sex":324,"minAge":325,"maxAge":55,"enrollmentInfo":326,"targetDuration":55,"studyType":329,"phases":330,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":91,"whyStopped":55,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":349},{"fullName":5,"class":6},"Acrivon Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":55},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Dose Escalation","To determine the MTD of ACR-2316.","Number of DLT events during the DLT observation period (up to 28 days)",{"measure":14,"description":15,"timeFrame":16},"Dose Expansion","To determine the RP2D of ACR-2316.","RP2D supported by safety, PK, PD, and emerging clinical activity data through study completion, an average of 1 year.",{"measure":14,"description":18,"timeFrame":19},"To assess the safety and tolerability of ACR-2316","Incidence and grades of TEAEs and TRAEs per NCI CTCAE v.5.0 and number of dose decreases, number of dose delays, and SAEs through study completion, an average of 1 year.",{"measure":14,"description":21,"timeFrame":22},"To determine preliminary anti-tumor activity of ACR-2316.","Confirmed ORR per Recist v1.1 and DOR, CBR, assessed every 6 weeks from baseline thorough study completion, an average 1 year or until death.",[24,27,30,32,34,36,38,40,42,44,46,47,48,49,50,51,52,53,54],{"measure":10,"description":25,"timeFrame":26},"To assess the safety and tolerability of ACR-2316. Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.","This will be evaluated through study completion, an average of 1 year.",{"measure":10,"description":28,"timeFrame":29},"To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).","Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.",{"measure":10,"description":31,"timeFrame":29},"To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).",{"measure":10,"description":33,"timeFrame":29},"To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).",{"measure":10,"description":35,"timeFrame":29},"To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).",{"measure":10,"description":37,"timeFrame":29},"To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).",{"measure":10,"description":39,"timeFrame":29},"To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).",{"measure":10,"description":41,"timeFrame":29},"To assess Pharmacokinetics: apparent volume of distribution (Vz\u002FF).",{"measure":10,"description":43,"timeFrame":29},"To assess Pharmacokinetics: terminal elimination half-life (t½).",{"measure":10,"description":45,"timeFrame":29},"To assess Pharmacokinetics: apparent oral clearance (CL\u002FF).",{"measure":14,"description":28,"timeFrame":29},{"measure":14,"description":31,"timeFrame":29},{"measure":14,"description":33,"timeFrame":29},{"measure":14,"description":35,"timeFrame":29},{"measure":14,"description":37,"timeFrame":29},{"measure":14,"description":39,"timeFrame":29},{"measure":14,"description":41,"timeFrame":29},{"measure":14,"description":43,"timeFrame":29},{"measure":14,"description":45,"timeFrame":29},null,{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":55,"timePerspective":55,"maskingInfo":61},"NON_RANDOMIZED","SEQUENTIAL","Dose escalation - Evaluable participants for dose limiting toxicity (DLT), maximum tolerated dose (MTD) determination for ACR-2316 administered per cohort\n\nDose expansion - participants with certain tumor types will be randomized 1:1 to receive1 of the 2 dose levels that will be selected for the determination of RP2D.","TREATMENT",{"masking":62,"maskingDescription":55,"whoMasked":55},"NONE","The Phase 1 monotherapy clinical trial for ACR-2316 is designed to assess the safety and tolerability of ACR-2316. Additional objectives include the determination of the maximal tolerated dose and recommended Phase 2 monotherapy dose, characterization of the pharmacokinetic profile and pharmacogenomics, and preliminary evaluation of anti-tumor activity.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"Dose escalation","EXPERIMENTAL","ACR-2316 will be administered using a 3-week or a 4-week schedule.",[70],"Drug: ACR-2316",{"label":72,"type":67,"description":68,"interventionNames":73},"Dose expansion",[70],[75],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":55},"DRUG","ACR-2316","ACR-2316 is an experimental drug",[66,72],[81,86],{"name":82,"role":83,"phone":84,"phoneExt":55,"email":85},"Mansoor R Mirza, MD","CONTACT","617-207-8979","ACR-2316ClinicalTrial@acrivon.com",{"name":87,"role":83,"phone":55,"phoneExt":55,"email":85},"Jeanie Tang",[89,109,124,138,153,168,183,198,213,227,242,257,272,287,301],{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"HonorHealth Research Institute","RECRUITING","Phoenix","Arizona","85016","United States","US",{"type":98,"coordinates":99},"Point",[100,101],-112.07404,33.44838,{"lat":101,"lon":100},[104,106],{"name":105,"role":83,"phone":55,"phoneExt":55,"email":55},"Amy Petersburg",{"name":107,"role":108,"phone":55,"phoneExt":55,"email":55},"Lyndsay Willmott, MD","PRINCIPAL_INVESTIGATOR",{"facility":110,"status":91,"city":111,"state":112,"zip":113,"country":95,"countryCode":96,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Precision NextGen Oncology & Research Center","Beverly Hills","California","90212",{"type":98,"coordinates":115},[116,117],-118.40036,34.07362,{"lat":117,"lon":116},[120,122],{"name":121,"role":83,"phone":55,"phoneExt":55,"email":55},"Francisco Capilla",{"name":123,"role":108,"phone":55,"phoneExt":55,"email":55},"Kamlesh K Sankhala, MD",{"facility":125,"status":91,"city":126,"state":112,"zip":127,"country":95,"countryCode":96,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Hoag Memorial Hospital Presbyterian","Newport Beach","92663",{"type":98,"coordinates":129},[130,131],-117.92895,33.61891,{"lat":131,"lon":130},[134,136],{"name":135,"role":83,"phone":55,"phoneExt":55,"email":55},"Ariel Klingfus",{"name":137,"role":108,"phone":55,"phoneExt":55,"email":55},"Monica Mita, MD",{"facility":139,"status":91,"city":140,"state":141,"zip":142,"country":95,"countryCode":96,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Denver Health One","Denver","Colorado","80218",{"type":98,"coordinates":144},[145,146],-104.9847,39.73915,{"lat":146,"lon":145},[149,151],{"name":150,"role":83,"phone":55,"phoneExt":55,"email":55},"Rachel Morgan",{"name":152,"role":108,"phone":55,"phoneExt":55,"email":55},"Gerald Falchook, MD",{"facility":154,"status":91,"city":155,"state":156,"zip":157,"country":95,"countryCode":96,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Florida Cancer Specialist","Sarasota","Florida","34232",{"type":98,"coordinates":159},[160,161],-82.53065,27.33643,{"lat":161,"lon":160},[164,166],{"name":165,"role":83,"phone":55,"phoneExt":55,"email":55},"Mallory Hawkins",{"name":167,"role":108,"phone":55,"phoneExt":55,"email":55},"Judy S Wang, MD",{"facility":169,"status":91,"city":170,"state":171,"zip":172,"country":95,"countryCode":96,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",{"type":98,"coordinates":174},[175,176],-71.05977,42.35843,{"lat":176,"lon":175},[179,181],{"name":180,"role":83,"phone":55,"phoneExt":55,"email":55},"Victoria Weden",{"name":182,"role":108,"phone":55,"phoneExt":55,"email":55},"Gerburg Wulf, MD",{"facility":184,"status":91,"city":185,"state":186,"zip":187,"country":95,"countryCode":96,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"University of Michigan","Ann Arbor","Michigan","48109",{"type":98,"coordinates":189},[190,191],-83.74088,42.27756,{"lat":191,"lon":190},[194,196],{"name":195,"role":83,"phone":55,"phoneExt":55,"email":55},"Fatima Darwiche",{"name":197,"role":108,"phone":55,"phoneExt":55,"email":55},"Zhen Ni Zhou, MD",{"facility":199,"status":91,"city":200,"state":201,"zip":202,"country":95,"countryCode":96,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Roswell Park Comprehensive Cancer Center","Buffalo","New York","14203",{"type":98,"coordinates":204},[205,206],-78.87837,42.88645,{"lat":206,"lon":205},[209,211],{"name":210,"role":83,"phone":55,"phoneExt":55,"email":55},"Paige Wierzbicki",{"name":212,"role":108,"phone":55,"phoneExt":55,"email":55},"Katherine LaVigne Mager, MD",{"facility":214,"status":91,"city":215,"state":201,"zip":216,"country":95,"countryCode":96,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Montefiore Medical Centre","The Bronx","10461",{"type":98,"coordinates":218},[219,220],-73.86641,40.84985,{"lat":220,"lon":219},[223,225],{"name":224,"role":83,"phone":55,"phoneExt":55,"email":55},"Sene Martin",{"name":226,"role":108,"phone":55,"phoneExt":55,"email":55},"Nicole Nevadunsky, MD",{"facility":228,"status":91,"city":229,"state":230,"zip":231,"country":95,"countryCode":96,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Carolina BioOncology Institute","Huntersville","North Carolina","28078",{"type":98,"coordinates":233},[234,235],-80.84285,35.41069,{"lat":235,"lon":234},[238,240],{"name":239,"role":83,"phone":55,"phoneExt":55,"email":55},"Hannah Wall",{"name":241,"role":108,"phone":55,"phoneExt":55,"email":55},"Neel Gandhi, MD",{"facility":243,"status":91,"city":244,"state":245,"zip":246,"country":95,"countryCode":96,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Rhode Island Hospital","Providence","Rhode Island","02903",{"type":98,"coordinates":248},[249,250],-71.41283,41.82399,{"lat":250,"lon":249},[253,255],{"name":254,"role":83,"phone":55,"phoneExt":55,"email":55},"Megan Faria",{"name":256,"role":108,"phone":55,"phoneExt":55,"email":55},"Benedito Carneiro, MD",{"facility":258,"status":91,"city":259,"state":260,"zip":261,"country":95,"countryCode":96,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Tennessee Oncology","Franklin","Tennessee","37067",{"type":98,"coordinates":263},[264,265],-86.86889,35.92506,{"lat":265,"lon":264},[268,270],{"name":269,"role":83,"phone":55,"phoneExt":55,"email":55},"Catt Pecknold",{"name":271,"role":108,"phone":55,"phoneExt":55,"email":55},"Jeff Russell, MD",{"facility":273,"status":91,"city":274,"state":275,"zip":276,"country":95,"countryCode":96,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77054",{"type":98,"coordinates":278},[279,280],-95.36327,29.76328,{"lat":280,"lon":279},[283,285],{"name":284,"role":83,"phone":55,"phoneExt":55,"email":55},"CR Registration Team Office of Clinical Research",{"name":286,"role":108,"phone":55,"phoneExt":55,"email":55},"Timothy A Yap, MD,PhD",{"facility":288,"status":91,"city":289,"state":275,"zip":290,"country":95,"countryCode":96,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"NEXT Oncology","San Antonio","78229",{"type":98,"coordinates":292},[293,294],-98.49363,29.42412,{"lat":294,"lon":293},[297,299],{"name":298,"role":83,"phone":55,"phoneExt":55,"email":55},"Jordan Georg",{"name":300,"role":108,"phone":55,"phoneExt":55,"email":55},"David Sommerhalder, MD",{"facility":302,"status":91,"city":303,"state":304,"zip":305,"country":95,"countryCode":96,"cosmosGeoPoint":306,"geoPoint":310,"contacts":311},"Next Virginia","Fairfax","Virginia","22031",{"type":98,"coordinates":307},[308,309],-77.30637,38.84622,{"lat":309,"lon":308},[312,314],{"name":313,"role":83,"phone":55,"phoneExt":55,"email":55},"Blake Patterson",{"name":315,"role":108,"phone":55,"phoneExt":55,"email":55},"Mohamad Salkeni, MD",{"type":317,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100567357",false,"NCT06667141","Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors","ACR-2316-101: Phase 1 Study of ACR-2316 in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Signed written informed consent.\n2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.\n3. Must be willing to provide redacted pathology report.\n4. Subjects should have received no more than 3 lines of systemic therapy for recurrent disease.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.\n6. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.\n7. Adequate organ functions.\n8. Must have progressed after prior line of treatment.\n\nExclusion Criteria (all participants):\n\n1. Participants with known symptomatic brain metastases.\n2. Participant had systemic therapy within 3 weeks prior to the first dose of study drug.\n3. Participant had radiation therapy for curative intent within 4 weeks prior to the first dose of study drug.\n4. Participant had palliative radiation therapy within 2 weeks prior to the first dose of study drug.\n5. Women who are pregnant or lactating.","ALL","18 Years",{"count":327,"type":328},100,"ESTIMATED","INTERVENTIONAL",[331],"PHASE1","This is a first in-human, Open-label Phase 1 study to assess the safety of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.",[334],"Specific Advanced Solid Tumors",[77,336,337,338,339],"WEE1","PKMYT1","Locally advanced, recurrent or metastatic solid tumors","P53","2026-03-20",{"date":342,"type":343},"2026-03-23","ACTUAL",{"date":345,"type":343},"2024-10-08",{"date":347,"type":328},"2026-12-12",{"name":5,"class":6},15]