[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05394103":3,"trial-entities:NCT05394103":188,"trial-summary:NCT05394103":199},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":27,"interventions":30,"primary_outcomes":43,"secondary_outcomes":47,"sex":58,"minimum_age":59,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":74,"locations":77,"central_contacts":180,"overall_officials":185,"references":186,"see_also_links":187},"NCT05394103","QRNT-009","Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors","A Phase 1\u002F2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose","RECRUITING","2026-08-30","2025-08","2025-08-17","2022-08-30","Qurient Co., Ltd.","INDUSTRY",false,"Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab",null,[19,20],"Advanced Cancer","Metastatic Cancer",[],"INTERVENTIONAL","TREATMENT",[25,26],"PHASE1","PHASE2",{"count":28,"type":29},130,"ESTIMATED",[31,39],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Q901","The study drug Q901 will be administered by IV infusion over a 30-minute period using a QW dosing schedule for 4 weeks, followed by a Q2W interval dosing schedule thereafter",[36,37,38],"Dose escalation (Q901)","Q901 + KEYTRUDA® (pembrolizumab) Cohorts","Q901 Single-Agent Expansion Cohorts",{"type":32,"name":40,"description":41,"armGroupLabels":42},"KEYTRUDA® (pembrolizumab)","KEYTRUDA® (pembrolizumab) will be administered Q6W",[37],[44],{"measure":45,"timeFrame":46},"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0","28 days of cycle 1 (each cycle is 28 days)",[48,51,53,55],{"measure":49,"timeFrame":50},"Change in the area under curve (AUC) of Q901","Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)",{"measure":52,"timeFrame":50},"Change in the maximum plasma concentration (Cmax) of Q901",{"measure":54,"timeFrame":50},"Change in the time of maximum plasma concentration (Tmax) of Q901",{"measure":56,"timeFrame":57},"Tumor response using RECIST version 1.1 throughout study","Baseline and at the end of every even cycle up to approximately 2 years (each cycle is 28 days)","ALL","18 Years",{"inclusion":61,"exclusion":68,"raw_text":73},[62,63,64,65,66,67],"Participants with histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, who have progressed following standard-of-care therapy or for whom there is no standard therapy that confers clinical benefit","Measurable disease per RECIST v 1.1","ECOG performance status 0,1 or 2","Life expectancy of at least 3 months","Age ≥ 18 years","Signed, written IRB-approved informed consent form",[69,70,71,72],"New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure within the past 6 months","Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\>470 msec (females) and \\>450 msec (males)","Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy","Active, poorly controlled autoimmune or inflammatory diseases","Inclusion Criteria:\n\n* Participants with histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, who have progressed following standard-of-care therapy or for whom there is no standard therapy that confers clinical benefit\n* Measurable disease per RECIST v 1.1\n* ECOG performance status 0,1 or 2\n* Life expectancy of at least 3 months\n* Age ≥ 18 years\n* Signed, written IRB-approved informed consent form\n\nExclusion Criteria:\n\n* New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure within the past 6 months\n* Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\>470 msec (females) and \\>450 msec (males)\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy\n* Active, poorly controlled autoimmune or inflammatory diseases",[75,76],"ADULT","OLDER_ADULT",[78,91,101,110,120,129,139,149,158,166,175],{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":88},"Mayo Clinic","Phoenix","Arizona","85054","United States",[85],{"name":86,"role":87},"See Central Contact","CONTACT",{"lat":89,"lon":90},33.44838,-112.07404,{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":83,"contacts":96,"geoPoint":98},"University of Southern California","Los Angeles","California","90033",[97],{"name":86,"role":87},{"lat":99,"lon":100},34.05223,-118.24368,{"facility":79,"status":8,"city":102,"state":103,"zip":104,"country":83,"contacts":105,"geoPoint":107},"Jacksonville","Florida","32224",[106],{"name":86,"role":87},{"lat":108,"lon":109},30.33218,-81.65565,{"facility":111,"status":8,"city":112,"state":113,"zip":114,"country":83,"contacts":115,"geoPoint":117},"Northwestern University","Chicago","Illinois","60611",[116],{"name":86,"role":87},{"lat":118,"lon":119},41.85003,-87.65005,{"facility":79,"status":8,"city":121,"state":122,"zip":123,"country":83,"contacts":124,"geoPoint":126},"Rochester","Minnesota","55905",[125],{"name":86,"role":87},{"lat":127,"lon":128},44.02163,-92.4699,{"facility":130,"status":8,"city":131,"state":132,"zip":133,"country":83,"contacts":134,"geoPoint":136},"Atlantic Health System Hospital","Morristown","New Jersey","07960",[135],{"name":86,"role":87},{"lat":137,"lon":138},40.79677,-74.48154,{"facility":140,"status":8,"city":141,"state":142,"zip":143,"country":83,"contacts":144,"geoPoint":146},"Mary Crowley Cancer Research","Dallas","Texas","75230",[145],{"name":86,"role":87},{"lat":147,"lon":148},32.78306,-96.80667,{"facility":150,"status":8,"city":151,"country":152,"contacts":153,"geoPoint":155},"National Cancer Center","Goyang-si","South Korea",[154],{"name":86,"role":87},{"lat":156,"lon":157},37.65639,126.835,{"facility":159,"status":8,"city":160,"country":152,"contacts":161,"geoPoint":163},"CHA University Bundang Medical Center","Seongnam-si",[162],{"name":86,"role":87},{"lat":164,"lon":165},37.43861,127.13778,{"facility":167,"status":168,"city":169,"country":152,"contacts":170,"geoPoint":172},"Asan Medical Center","NOT_YET_RECRUITING","Seoul",[171],{"name":86,"role":87},{"lat":173,"lon":174},37.566,126.9784,{"facility":176,"status":168,"city":169,"country":152,"contacts":177,"geoPoint":179},"Severance Hospital",[178],{"name":86,"role":87},{"lat":173,"lon":174},[181],{"name":182,"role":87,"phone":183,"email":184},"Qurient Clinical Trial Information","+82-31-8060-1610","clinicaltrial_info@qurient.com",[],[],[],{"nct_id":4,"conditions":189,"biomarkers":198},[190,191,192,193,194,195,196,197],"Breast Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Lung Small Cell Carcinoma","Malignant Ovarian Neoplasm","Pancreatic Carcinoma","Prostate Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":200,"summary":201,"prompt_version":211},true,{"design":202,"status":203,"heading":204,"summary":205,"follow_up":206,"word_count":207,"commitments":208,"compensation":209,"drugs_mentioned":210},"This is a multicenter, open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 130 participants.","completed","Q901 for Advanced Solid Tumors","This study is testing a new drug called Q901, alone and in combination with KEYTRUDA® (pembrolizumab), for people with advanced or metastatic (spread to other parts of the body) ovarian, prostate, breast, endometrial, colorectal, small-cell lung, or pancreatic cancer. You might be able to join if your cancer has progressed after standard treatments or if there are no standard treatments that help. The main goal is to see how safe Q901 is and what side effects it causes. Researchers are also looking for signs that the treatment is helping to shrink tumors. The study is currently recruiting participants.","The study will assess treatment-related side effects for at least 28 days after the start of each treatment cycle.",98,"Q901 will be given through an IV for 30 minutes once a week for 4 weeks, then every two weeks. KEYTRUDA® will be given every 6 weeks.","Not stated in the trial record.",[33,40],"v2"]