[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06804824":3,"trial-entities:NCT06804824":189,"trial-summary:NCT06804824":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":20,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":53,"secondary_outcomes":64,"sex":90,"minimum_age":91,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":92,"std_ages":108,"locations":111,"central_contacts":180,"overall_officials":186,"references":187,"see_also_links":188},"NCT06804824","VVD-159642-01","A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b, Open-Label, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-159642, a RAS-PI3Kα Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors","RECRUITING","2027-08-01","2026-03","2026-03-18","2025-02-25","Vividion Therapeutics, Inc.","INDUSTRY",false,"A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.",null,[19],"Advanced Solid Tumors",[21,22,23,24,25,26,27,28],"RAS","PI3K","KRAS","MEK","Phase I","solid tumors","KRAS G12C","HER2","INTERVENTIONAL","TREATMENT",[32],"PHASE1",{"count":34,"type":35},220,"ESTIMATED",[37,46,50],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DRUG","VVD-159642","Oral capsules",[42,43,44,45],"Part 1: Dose Escalation: VVD-159642 Single Agent","Part 2: Dose Expansion (Cohort A): VVD-159642 Single Agent","Part 2: Dose Expansion (Cohort B): VVD-159642 + Sotorasib","Part 2: Dose Expansion (Cohort C): VVD-159642 + Trametinib",{"type":38,"name":47,"description":48,"armGroupLabels":49},"Sotorasib","Oral tablets",[44],{"type":38,"name":51,"description":48,"armGroupLabels":52},"Trametinib",[45],[54,57,60,62],{"measure":55,"timeFrame":56},"Part 1: Incidence and Severity of Dose-limiting Toxicities (DLTs)","From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]",{"measure":58,"timeFrame":59},"Part 2: Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)","Up to approximately 29 months",{"measure":61,"timeFrame":59},"Part 2: Incidence and Severity of Clinically Significant Changes in Vital Signs",{"measure":63,"timeFrame":59},"Part 2: Incidence and Severity of Clinically Significant Changes in Laboratory Evaluations",[65,68,71,74,77,80,83,86,88],{"measure":66,"description":67,"timeFrame":59},"Part 1: Recommended Dose for Expansion (RDE) of VVD-159642 as a Single Agent","The RDE will be based on safety, tolerability, PK, and preliminary anti-tumor activity of VVD-159642 as a single agent during the dose escalation phase.",{"measure":69,"description":70,"timeFrame":59},"Part 2: Recommended Phase 2 Dose (RP2D) of VVD-159642 as a Single Agent and in Combination with Sotorasib and Trametinib","The RP2D will be based on safety, tolerability, PK and preliminary anti-tumor activity of VVD-159642 as single agent, and in combination with sotorasib and trametinib during Part 2.",{"measure":72,"description":73,"timeFrame":59},"Part 2: Overall Response Rate (ORR)","ORR is defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.",{"measure":75,"description":76,"timeFrame":59},"Part 2: Duration of Response (DoR)","DOR is defined as the time from initial response of CR or PR to progressive disease or death, whichever comes first per RECIST version 1.1 by investigator assessment.",{"measure":78,"description":79,"timeFrame":59},"Part 2: Progression-free Survival (PFS)","PFS is defined as the time from the date of randomization to the time of confirmed disease progression or death, whichever occurs first per RECIST version 1.1 by investigator assessment.",{"measure":81,"description":82,"timeFrame":59},"Part 2: Disease Control Rate (DCR)","DCR is defined as the percentage of participants achieving CR or PR, or stable disease (SD) per RECIST version 1.1 by investigator assessment.",{"measure":84,"timeFrame":85},"Parts 1 and 2: Area Under the Plasma Concentration-time Curve (AUC) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib","Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)",{"measure":87,"timeFrame":85},"Parts 1 and 2: Maximum Plasma Concentration (Cmax) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib",{"measure":89,"timeFrame":85},"Parts 1 and 2: Half-life (t1\u002F2) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib","ALL","18 Years",{"inclusion":93,"exclusion":100,"raw_text":107},[94,95,96,97,98,99],"For Part 1 Dose Escalation, the prospective participant must have histologically confirmed pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), or any solid tumor that harbors a rat sarcoma viral oncogene (RAS) alteration \\[Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), Harvey rat sarcoma viral oncogene homolog (HRAS)\\] as per local \u002Fhistorical testing; any solid tumor that harbors an epidermal growth factor receptor (EGFR) alteration as per local\u002Fhistorical testing; or human epidermal growth factor receptor 2 (HER2) overexpression (immunohistochemistry \\[IHC\\] 3+ or IHC 2+\u002Ffluorescence in situ hybridization \\[FISH\\] positive) as per local\u002Fhistorical testing.","Have histologically or cytologically confirmed metastatic or unresectable solid tumors.","Measurable disease by RECIST version 1.1 as assessed by the investigator.","Eastern Cooperative Oncology Group (ECOG) performance status ≤1.","Adequate bone marrow, kidney, and liver function as defined in the protocol.","Able to take oral medications.",[101,102,103,104,105,106],"Active central nervous system (CNS) malignancies.","History of cardiac diseases as defined in detail in the protocol.","Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).","History of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and\u002For may interfere with the conduct of the study.","Active hepatitis B infection \\[positive for hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (DNA)\\].","Active hepatitis C infection (positive anti-hepatitis C virus \\[HCV\\] antibody and quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay).","Key Inclusion Criteria:\n\n* For Part 1 Dose Escalation, the prospective participant must have histologically confirmed pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), or any solid tumor that harbors a rat sarcoma viral oncogene (RAS) alteration \\[Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), Harvey rat sarcoma viral oncogene homolog (HRAS)\\] as per local \u002Fhistorical testing; any solid tumor that harbors an epidermal growth factor receptor (EGFR) alteration as per local\u002Fhistorical testing; or human epidermal growth factor receptor 2 (HER2) overexpression (immunohistochemistry \\[IHC\\] 3+ or IHC 2+\u002Ffluorescence in situ hybridization \\[FISH\\] positive) as per local\u002Fhistorical testing.\n* Have histologically or cytologically confirmed metastatic or unresectable solid tumors.\n* Measurable disease by RECIST version 1.1 as assessed by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n* Adequate bone marrow, kidney, and liver function as defined in the protocol.\n* Able to take oral medications.\n\nKey Exclusion Criteria:\n\n* Active central nervous system (CNS) malignancies.\n* History of cardiac diseases as defined in detail in the protocol.\n* Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).\n* History of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and\u002For may interfere with the conduct of the study.\n* Active hepatitis B infection \\[positive for hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (DNA)\\].\n* Active hepatitis C infection (positive anti-hepatitis C virus \\[HCV\\] antibody and quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay).",[109,110],"ADULT","OLDER_ADULT",[112,121,129,136,143,147,155,163,172],{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":117,"geoPoint":118},"START Mid West","Grand Rapids","Michigan","49546","United States",{"lat":119,"lon":120},42.96336,-85.66809,{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":117,"geoPoint":126},"NEXT Austin","Austin","Texas","78758",{"lat":127,"lon":128},30.26715,-97.74306,{"facility":130,"status":8,"city":131,"state":124,"zip":132,"country":117,"geoPoint":133},"NEXT Dallas","Irving","75039",{"lat":134,"lon":135},32.81402,-96.94889,{"facility":137,"status":8,"city":138,"state":124,"zip":139,"country":117,"geoPoint":140},"START San Antonio","San Antonio","78229",{"lat":141,"lon":142},29.42412,-98.49363,{"facility":144,"status":8,"city":138,"state":124,"zip":145,"country":117,"geoPoint":146},"NEXT San Antonio","78299",{"lat":141,"lon":142},{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":117,"geoPoint":152},"START Mountain","Ogden","Utah","84401",{"lat":153,"lon":154},41.223,-111.97383,{"facility":156,"status":8,"city":157,"state":158,"zip":159,"country":117,"geoPoint":160},"NEXT Virginia","Fairfax","Virginia","22031",{"lat":161,"lon":162},38.84622,-77.30637,{"facility":164,"status":8,"city":165,"state":166,"zip":167,"country":168,"geoPoint":169},"Clinical Research South Australia (CRSA)","Adelaide","South Australia","5000","Australia",{"lat":170,"lon":171},-34.92866,138.59863,{"facility":173,"status":8,"city":174,"state":175,"zip":176,"country":168,"geoPoint":177},"Linear Clinical","Nedlands","Western Australia","6009",{"lat":178,"lon":179},-31.98184,115.8073,[181],{"name":182,"role":183,"phone":184,"email":185},"Vividion Clinical Trial Call Center","CONTACT","858-345-9752","clinicaltrials@vividion.com",[],[],[],{"nct_id":4,"conditions":190,"biomarkers":195},[191,192,193,194],"Colorectal Carcinoma","Lung Non-Small Cell Carcinoma","Pancreatic Ductal Adenocarcinoma","Solid Neoplasm",[196,197,198],"ERBB2 Gene","RAS Family Oncogene","Soluble Epidermal Growth Factor Receptor",{"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 an interventional study, meaning participants will receive a specific treatment. It is a \"first-in-human\" study and plans to enroll 220 participants.","completed","Study of VVD-159642 for Advanced Solid Tumors","This study is testing a new drug called VVD-159642 in people with advanced solid tumors. Researchers want to see how safe VVD-159642 is and how well your body handles it, both alone and when combined with sotorasib or trametinib. You might be able to join if you have certain advanced solid tumors like pancreatic, colorectal, or non-small cell lung cancer, and your tumor has specific genetic changes (like KRAS or NRAS). The study will look at side effects and how your vital signs (like heart rate and blood pressure) change. This is a \"first-in-human\" study, meaning it's one of the first times this drug is being tested in people. The study aims to enroll 220 participants, but its current recruitment status is unclear.","Participants in Part 2 of the study will be monitored for adverse events and changes in vital signs for up to approximately 29 months.",123,"Not specified in the trial record.","Not stated in the trial record.",[39,47,51],"v2"]