[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pliant Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":59},{"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":24,"conditions":25,"keywords":27,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"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":19,"type":20},124,"ESTIMATED","INTERVENTIONAL",[23],"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",[26],"Advanced or Metastatic Solid Tumor",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"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","Pembrolizumab","Immunotherapy","RECRUITING","2026-04-15",{"date":49,"type":50},"2026-04-20","ACTUAL",{"date":52,"type":50},"2023-08-30",{"date":54,"type":20},"2030-06",{"name":56,"class":57},"Pliant Therapeutics, Inc.","INDUSTRY",6,""]