[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07584226":3,"trial-entities:NCT07584226":216,"trial-summary:NCT07584226":222},{"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":30,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":46,"secondary_outcomes":56,"sex":76,"minimum_age":77,"maximum_age":15,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":92,"locations":95,"central_contacts":208,"overall_officials":213,"references":214,"see_also_links":215},"NCT07584226","RLY-8161-101","A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors","A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors","RECRUITING","2029-12-31","2026-06","2026-07-02","2026-03-09","Relay Therapeutics, Inc.","INDUSTRY",null,"This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma and other solid tumors.","This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma and other solid tumors. This study consists of 2 parts: dose escalation (Part 1) and dose expansion (Part 2).\n\nPart 1, dose escalation will explore multiple ascending doses of RLY-8161 in participants with any advanced NRAS-mutant solid tumor until maximum tolerated dose is reached or one or more recommended Phase 2 dose (RP2D) is identified.\n\nPart 2, dose expansion will be at the RP2D(s) identified in Part 1 in NRAS-mutant solid tumors.",[19,20,21,22,23,24,25,26,27,28,29],"Advanced NRAS-Mutant Melanoma","Advanced NRAS-Mutant Solid Tumors","NRAS Mutation","NRAS G12D","NRAS G13R","NRAS G13D","NRAS G12V","NRAS Q61R","NRAS Q61K","NRAS Q61L","NRAS Q61H",[],"INTERVENTIONAL","TREATMENT",[34],"PHASE1",{"count":36,"type":37},35,"ESTIMATED",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43},"DRUG","RLY-8161","RLY-8161 is an NRAS-selective inhibitor",[44,45],"Part 1: RLY-8161 for participants with advanced NRAS-mutant solid tumors","Part 2: RLY-8161 for participants with advanced NRAS-mutant solid tumors",[47,50,53],{"measure":48,"timeFrame":49},"Part 1: Maximum Tolerated Dose (MTD) and\u002For RP2D of RLY-8161","Cycle 1 (28-day cycle) of treatment for MTD and at the end of every cycle (28-day cycle) for RP2D until treatment discontinuation, approximately 12 months",{"measure":51,"timeFrame":52},"Part 1: Number of participants with Adverse Events (AEs) or Serious Adverse Events (SAEs), with changes in vital signs, electrocardiograms (ECGs), and laboratory tests","Cycle 1 (28-day cycle) of treatment and at the end of every cycle (28-day cycle) until 30 days after treatment discontinuation, approximately 13 months",{"measure":54,"timeFrame":55},"Part 2: Objective Response Rate (ORR) of RLY-8161 as assessed by RECIST v1.1","Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months",[57,60,63,65,67,69,71,74],{"measure":58,"timeFrame":59},"Part 1 and Part 2: Changes in NRAS mutant allele fraction in ctDNA","Approximately every 2 weeks in Cycle 1 (28-day cycle), at the beginning of Cycle 2 (28-day cycle), and at the beginning of every odd cycle (28-day cycle) until End of Treatment (EOT), approximately 12 months",{"measure":61,"timeFrame":62},"Part 1 and Part 2: Plasma concentration and PK parameters of RLY-8161","Approximately every 2 weeks in Cycle 1 (28-day cycle) and at Day 1 of every cycle (28-day cycle) through Cycle 4",{"measure":64,"timeFrame":55},"Part 1: ORR of RLY-8161 as assessed by RECIST v1.1",{"measure":66,"timeFrame":55},"Part 1 and 2: Duration of Response (DOR) of RLY-8161 as assessed by RECIST v1.1",{"measure":68,"timeFrame":55},"Part 1 and 2: Disease Control Rate (DCR) of RLY-8161 as assessed by RECIST v1.1",{"measure":70,"timeFrame":55},"Part 2: Progression-free survival (PFS) as assessed by RECIST v1.1",{"measure":72,"timeFrame":73},"Part 2: Overall Survival","Cycle 1 (28-day cycles) until study completion, approximately 30 months",{"measure":75,"timeFrame":52},"Part 2: Number of participants with AEs or SAEs, with changes in vital signs, ECGs, and laboratory tests","ALL","18 Years",false,{"inclusion":80,"exclusion":86,"raw_text":91},[81,82,83,84,85],"Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.","Histologically confirmed diagnosis of unresectable Stage III or IV melanoma or other solid tumor.","Disease is refractory to standard therapy (including targeted therapy), participant is intolerant of standard therapy, or participant has declined standard therapy.","Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.","One or more documented primary oncogenic NRAS mutation(s).",[87,88,89,90],"Known activating KRAS, HRAS, or BRAF mutation or known alterations in other driver oncogenes.","Prior treatment with ERK, MEK, RAF, or RAS targeting agents or any agent whose mechanism of action is to inhibit the RAS-MAPK pathway.","For participants with melanoma: lactate dehydrogenase (LDH) \\>2×ULN.","Central nervous system (CNS) metastases that are associated with progressive neurologic symptoms or require ongoing corticosteroids to control the CNS disease.","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Histologically confirmed diagnosis of unresectable Stage III or IV melanoma or other solid tumor.\n* Disease is refractory to standard therapy (including targeted therapy), participant is intolerant of standard therapy, or participant has declined standard therapy.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* One or more documented primary oncogenic NRAS mutation(s).\n\nExclusion Criteria:\n\n* Known activating KRAS, HRAS, or BRAF mutation or known alterations in other driver oncogenes.\n* Prior treatment with ERK, MEK, RAF, or RAS targeting agents or any agent whose mechanism of action is to inhibit the RAS-MAPK pathway.\n* For participants with melanoma: lactate dehydrogenase (LDH) \\>2×ULN.\n* Central nervous system (CNS) metastases that are associated with progressive neurologic symptoms or require ongoing corticosteroids to control the CNS disease.",[93,94],"ADULT","OLDER_ADULT",[96,111,123,136,149,158,170,182,195],{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":108},"University of California, Los Angeles","Los Angeles","California","90095","United States",[103],{"name":104,"role":105,"phone":106,"email":107},"Bartosz Chmielowski, MD","CONTACT","310-794-4655","bchmielowski@mednet.ucla.edu",{"lat":109,"lon":110},34.05223,-118.24368,{"facility":112,"status":8,"city":113,"state":99,"zip":114,"country":101,"contacts":115,"geoPoint":120},"University of California, San Francisco","San Francisco","94143",[116],{"name":117,"role":105,"phone":118,"email":119},"Sonia C Martinez","415-714-4484","Sonia.ContrerasMartinez@ucsf.edu",{"lat":121,"lon":122},37.77493,-122.41942,{"facility":124,"status":8,"city":125,"state":126,"zip":127,"country":101,"contacts":128,"geoPoint":133},"University of Colorado Hospital","Aurora","Colorado","80045",[129],{"name":130,"role":105,"phone":131,"email":132},"Meagan Brander","303-724-8869","MAEGAN.BRANDER@CUANSCHUTZ.EDU",{"lat":134,"lon":135},39.72943,-104.83192,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":101,"contacts":141,"geoPoint":146},"Massachusetts General Hospital","Boston","Massachusetts","02114",[142],{"name":143,"role":105,"phone":144,"email":145},"Ryan Sullivan, MD","617-243-5480","RSULLIVAN7@mgh.harvard.edu",{"lat":147,"lon":148},42.35843,-71.05977,{"facility":150,"status":8,"city":138,"state":139,"zip":151,"country":101,"contacts":152,"geoPoint":157},"Dana Farber Cancer Institute","02215",[153],{"name":154,"role":105,"phone":155,"email":156},"Linnea Drew","617-632-6704","Linneam_drew@dfci.harvard.edu",{"lat":147,"lon":148},{"facility":159,"status":8,"city":160,"state":161,"zip":162,"country":101,"contacts":163,"geoPoint":167},"START Midwest, LLC","Grand Rapids","Michigan","49546",[164],{"role":105,"phone":165,"email":166},"616-954-5554","hopeteam@startresearch.com",{"lat":168,"lon":169},42.96336,-85.66809,{"facility":171,"status":8,"city":172,"state":172,"zip":173,"country":101,"contacts":174,"geoPoint":179},"Memorial Sloan Kettering Cancer Center","New York","10065",[175],{"name":176,"role":105,"phone":177,"email":178},"Monica Chen, MD","646-888-5108","ChenM9@mskcc.org",{"lat":180,"lon":181},40.71427,-74.00597,{"facility":183,"status":8,"city":184,"state":185,"zip":186,"country":101,"contacts":187,"geoPoint":192},"Sarah Cannon Research Institute Oncology Partners","Nashville","Tennessee","37203",[188],{"name":189,"role":105,"phone":190,"email":191},"ASKSarah","877-MY-1-SCRI (691-7274)","ASKSARAH@scresearch.net",{"lat":193,"lon":194},36.16589,-86.78444,{"facility":196,"status":8,"city":197,"state":198,"zip":199,"country":101,"contacts":200,"geoPoint":205},"NEXT Virginia","Fairfax","Virginia","22031",[201],{"name":202,"role":105,"phone":203,"email":204},"Paolo Umayam","703-783-4546","pumayam@nextoncology.com",{"lat":206,"lon":207},38.84622,-77.30637,[209],{"name":210,"role":105,"phone":211,"email":212},"Relay Therapeutics, Inc","617-322-0731","ClinicalTrials@relaytx.com",[],[],[],{"nct_id":4,"conditions":217,"biomarkers":220},[218,219],"Melanoma","Solid Neoplasm",[221],"NRAS Gene",{"nct_id":4,"found":223,"summary":224,"prompt_version":234},true,{"design":225,"status":226,"heading":227,"summary":228,"follow_up":229,"word_count":230,"commitments":231,"compensation":232,"drugs_mentioned":233},"This is a Phase 1, open-label (meaning you and your doctors will know what treatment you are receiving) study involving multiple centers. It plans to enroll 35 participants.","completed","RLY-8161 for Advanced NRAS-Mutant Solid Tumors","This study is testing a new drug called RLY-8161 for people with advanced solid tumors, including melanoma, that have a specific genetic change called an NRAS mutation. RLY-8161 is designed to target and block the NRAS mutation. The study aims to find the safest and most effective dose of RLY-8161, understand its side effects, and see if it can shrink tumors. You might be able to join if you have unresectable (cannot be removed by surgery) Stage III or IV melanoma or another solid tumor with an NRAS mutation, and your disease has not responded to standard treatments, or you cannot tolerate them, or have chosen not to have them. The study will measure how many participants experience tumor shrinkage.","You would be followed for safety for about 30 days after stopping treatment, and for tumor response for approximately 18 months.",120,"Not specified in the trial record.","Not stated in the trial record.",[41],"v2"]