[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536890":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":68,"centralContacts":72,"locations":76,"responsibleParty":219,"collaborators":49,"id":221,"slug":222,"hasResults":223,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":49,"eligibilityCriteria":227,"healthyVolunteers":223,"sex":228,"minAge":229,"maxAge":49,"enrollmentInfo":230,"targetDuration":49,"studyType":233,"phases":234,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":93,"whyStopped":49,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":266},{"fullName":5,"class":6},"Pliant Therapeutics, Inc.","INDUSTRY",[8,15,19,23,27,31,35,39],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 Dose Escalation - 250 mg BID","EXPERIMENTAL","Cohort 1 PLN-101095 250 mg BID in combination with pembrolizumab in participants with solid tumors",[13,14],"Drug: PLN-101095","Drug: Pembrolizumab",{"label":16,"type":10,"description":17,"interventionNames":18},"Part 1 Dose Escalation - 500 mg BID","PLN-101095 500 mg BID in combination with pembrolizumab in participants with solid tumors",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Part 1 Dose Escalation - 1000 mg BID","PLN-101095 1000 mg BID in combination with pembrolizumab in participants with solid tumors",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Part 1 Dose Escalation - 1000 mg TID","PLN-101095 1000 mg TID in combination with pembrolizumab in participants with solid tumors",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Part 1 Dose Escalation - 2000 mg BID","PLN-101095 2000 mg BID in combination with pembrolizumab in participants with solid tumors",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Part 2 Dose Expansion - NSCLC","PLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Non-small cell lung cancer (NSCLC)",[13,14],{"label":36,"type":10,"description":37,"interventionNames":38},"Part 2 Dose Expansion - ccRCC","PLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Clear cell renal cell carcinoma (ccRCC)",[13,14],{"label":40,"type":10,"description":41,"interventionNames":42},"Part 2 Dose Expansion - TMB-high solid tumors","PLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Tumor mutational burden (TMB)-high solid tumors",[13,14],[44,50,53,56,59,62,64],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","PLN-101095","PLN-101095 250 mg BID",[9],null,{"type":45,"name":46,"description":51,"armGroupLabels":52,"otherNames":49},"PLN-101095 500 mg BID",[16],{"type":45,"name":46,"description":54,"armGroupLabels":55,"otherNames":49},"PLN-101095 1000 mg BID",[20],{"type":45,"name":46,"description":57,"armGroupLabels":58,"otherNames":49},"PLN-101095 1000 mg TID",[24],{"type":45,"name":46,"description":60,"armGroupLabels":61,"otherNames":49},"PLN-101095 2000 mg BID",[28],{"type":45,"name":46,"description":46,"armGroupLabels":63,"otherNames":49},[32,40,36],{"type":45,"name":65,"description":66,"armGroupLabels":67,"otherNames":49},"Pembrolizumab","Pembrolizumab (KEYTRUDA) 200 mg IV Q3W",[20,24,28,9,16,32,40,36],[69],{"name":70,"affiliation":5,"role":71},"Pliant Therapeutics Medical Monitor","STUDY_DIRECTOR",[73],{"name":70,"role":74,"phone":75,"phoneExt":49,"email":75},"CONTACT","clintrials@pliantrx.com",[77,91,104,116,128,140,153,165,176,187,195,207],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":49},"Yale University","ACTIVE_NOT_RECRUITING","New Haven","Connecticut","06511","United States","US",{"type":86,"coordinates":87},"Point",[88,89],-72.92816,41.30815,{"lat":89,"lon":88},{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":83,"countryCode":84,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Winship Cancer Institute of Emory University","RECRUITING","Atlanta","Georgia","30322",{"type":86,"coordinates":98},[99,100],-84.38798,33.749,{"lat":100,"lon":99},[103],{"name":70,"role":74,"phone":49,"phoneExt":49,"email":75},{"facility":105,"status":93,"city":106,"state":107,"zip":108,"country":83,"countryCode":84,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"South Texas Accelerated Research Therapeutics (START)","Grand Rapids","Michigan","49546",{"type":86,"coordinates":110},[111,112],-85.66809,42.96336,{"lat":112,"lon":111},[115],{"name":70,"role":74,"phone":49,"phoneExt":49,"email":75},{"facility":117,"status":93,"city":118,"state":119,"zip":120,"country":83,"countryCode":84,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"START New Jersey","East Brunswick","New Jersey","08816",{"type":86,"coordinates":122},[123,124],-74.41598,40.42788,{"lat":124,"lon":123},[127],{"name":70,"role":74,"phone":49,"phoneExt":49,"email":75},{"facility":129,"status":93,"city":130,"state":131,"zip":132,"country":83,"countryCode":84,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"START New York Long Island LLC","Lake Success","New York","11042",{"type":86,"coordinates":134},[135,136],-73.71763,40.77066,{"lat":136,"lon":135},[139],{"name":70,"role":74,"phone":49,"phoneExt":49,"email":75},{"facility":141,"status":93,"city":142,"state":143,"zip":144,"country":83,"countryCode":84,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Carolina Cancer Research Center","Wilson","North Carolina","27893",{"type":86,"coordinates":146},[147,148],-77.91554,35.72127,{"lat":148,"lon":147},[151],{"name":152,"role":74,"phone":49,"phoneExt":49,"email":75},"Pliant Therapeutics Medical Monitor Medical Monitor",{"facility":154,"status":93,"city":155,"state":156,"zip":157,"country":83,"countryCode":84,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"NEXT Austin","Austin","Texas","78758",{"type":86,"coordinates":159},[160,161],-97.74306,30.26715,{"lat":161,"lon":160},[164],{"name":70,"role":74,"phone":49,"phoneExt":49,"email":75},{"facility":166,"status":93,"city":167,"state":156,"zip":168,"country":83,"countryCode":84,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"START Center for Clinical Research","Fort Worth","76104",{"type":86,"coordinates":170},[171,172],-97.32085,32.72541,{"lat":172,"lon":171},[175],{"name":70,"role":74,"phone":49,"phoneExt":49,"email":75},{"facility":177,"status":93,"city":178,"state":156,"zip":179,"country":83,"countryCode":84,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"University of Texas MD Anderson Cancer Center","Houston","77030",{"type":86,"coordinates":181},[182,183],-95.36327,29.76328,{"lat":183,"lon":182},[186],{"name":70,"role":74,"phone":49,"phoneExt":49,"email":75},{"facility":188,"status":93,"city":178,"state":156,"zip":189,"country":83,"countryCode":84,"cosmosGeoPoint":190,"geoPoint":192,"contacts":193},"NEXT Houston","77054",{"type":86,"coordinates":191},[182,183],{"lat":183,"lon":182},[194],{"name":70,"role":74,"phone":49,"phoneExt":49,"email":75},{"facility":196,"status":93,"city":197,"state":198,"zip":199,"country":83,"countryCode":84,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"START Mountain Region","West Valley City","Utah","84119",{"type":86,"coordinates":201},[202,203],-112.00105,40.69161,{"lat":203,"lon":202},[206],{"name":70,"role":74,"phone":49,"phoneExt":49,"email":75},{"facility":208,"status":93,"city":209,"state":210,"zip":211,"country":83,"countryCode":84,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"NEXT Virginia","Fairfax","Virginia","22031",{"type":86,"coordinates":213},[214,215],-77.30637,38.84622,{"lat":215,"lon":214},[218],{"name":70,"role":74,"phone":49,"phoneExt":49,"email":75},{"type":220,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100536890","phase-1-a-phase-1-study-of-pln-101095-in-adults-with-advanced-or-metastatic-solid-tumors-100536890",false,"NCT06270706","A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors","A Phase 1a\u002F1b Multicenter, Open-label Dose Escalation\u002FExpansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on an Immune Checkpoint Inhibitor (FORTIFY)","Inclusion Criteria:\n\n1. Has histologically or cytologically confirmed advanced or metastatic solid tumor\n2. Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies\n3. Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only)\n4. Must have subsequently developed radiographic disease progression while receiving anti-PD-1 or anti-PD-L1 treatment or within ≤12 weeks after the last dose of such treatment\n5. At least 1 measurable lesion, as defined by RECIST v1.1\n6. Estimated survival of ≥3 months\n7. Have adequate bone marrow and organ function.\n8. A female participant is eligible to participate if she is not pregnant, not breastfeeding\n\nExclusion Criteria:\n\n1. Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab\n2. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years\n3. Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy\n4. Has undergone major surgery within 4 weeks prior to the first dose of study treatment or has not adequately recovered from surgery or related complications\n5. Has a diagnosis of immunodeficiency or use of systemic steroids \\>10 mg\u002Fday\n6. Has an active autoimmune disease that has required systemic treatment in the past 2 years\n7. Has known active CNS metastases (brain and\u002For leptomeningeal metastases)\n8. Has significant cardiac disease\n9. Has an active infection requiring systemic therapy (including uncontrolled HIV, Hepatitis B and C)\n10. Has received a live or live-attenuated vaccine within 30 days or a non-live vaccine within 7 days prior to the first dose of PLN-101095","ALL","18 Years",{"count":231,"type":232},124,"ESTIMATED","INTERVENTIONAL",[235],"PHASE1","This is a Phase 1a\u002F1b, dose-escalation\u002Fexpansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \\[primary resistance\\]) or relapsed \\[secondary resistance\\]) after at least 3 months from the start of treatment with pembrolizumab.\n\nThe study will consist of 2 main parts:\n\n* Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design with accelerated titration\n* Part 2: Dose-expansion cohorts using Simon's 2-stage design",[238],"Advanced or Metastatic Solid Tumor",[240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,65,256],"Advanced Solid Tumors Cancer","Anal Carcinoma","Biliary tract carcinoma (BTC)","Cholangiocarcinoma","Clear cell renal cell carcinoma (ccRCC)","Colorectal Cancer","Endometrial Cancer","Gallbladder","Head and Neck Squamous Cell Cancer (HNSCC)","Melanoma","Non-small cell lung cancer (NSCLC)","Ovarian Carcinoma","Triple Negative Breast Cancer (TNBC)","Tumor mutational burden (TMB)-high tumors","TMB-low tumors","Urothelial Carcinoma","Immunotherapy","2026-07-30",{"date":259,"type":260},"2026-08-03","ACTUAL",{"date":262,"type":260},"2023-08-30",{"date":264,"type":232},"2030-06",{"name":5,"class":6},12]