[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vividion Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,76],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100516417","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-anti-tumor-activity-of-vvd-133214-as-monotherapy-and-in-combination-in-participants-with-advanced-solid-tumors-100516417",false,"NCT06004245","A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors","A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors Harboring Microsatellite Instability (MSI) and\u002For Deficient Mismatch Repair (dMMR)","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Have a microsatellite instability (MSI) and\u002For deficient mismatch repair (dMMR), histologically or cytologically documented advanced (unresectable and\u002For metastatic) solid tumor; For the combination with bevacizumab only: advanced, or metastatic colorectal adenocarcinoma (CRC) treated with at least 2 but no more than 3 prior lines of systemic therapy for the treatment of advanced CRC; For the combination with pembrolizumab only: Histologically confirmed locally advanced, or metastatic CRC with no prior systemic treatment for metastatic disease and not amenable to surgery\n* Have received and then progressed following, or are intolerant to, standard therapy in the advanced setting\n* Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n* Life expectancy of at least (≥)12 weeks\n* Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor\u002Fcentral laboratory for retrospective central testing; for participants without archival tissue, a biopsy from either primary or metastatic tumor lesion, deemed medically feasible, must be taken\n* Adequate hematologic, end-organ, and cardiovascular function, as defined in the protocol\n\nExclusion Criteria:\n\n* Inability or unwillingness to swallow pills\n* Malabsorption syndrome or other condition that would interfere with enteral absorption\n* Known hypersensitivity or intolerance to ingredients from the study drug formulation including patients with rare genetic disorders such as galactosaemia, glucose-galactose intolerance or congenital lactase deficiency\n* Known uncontrolled central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) and\u002For carcinomatous meningitis\n* Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis and atypical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds), or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 2 weeks prior to the start of drug administration (related to the completion of the course of antibiotics, except if for tumor fever) or 6 months for any intracranial abscess\n* Has a positive test at screening for hepatitis B virus, hepatitis C virus, or for human immodeficiency virus (HIV), per local diagnostic standard and in accordance with local laws and regulations\n* Uncontrolled diabetes or symptomatic hyperglycemia (i.e., well controlled defined as a screening hemoglobin A1c \\\u003C8% and no urinary ketoacidosis)\n* Significant cardiovascular\u002Fcerebrovascular disease within 6 months prior to Day 1 of study drug administration\n* Alcohol or drug dependence or abuse\n* Patients with known Werner (WRN) syndrome\n* Prior treatment with any WRN helicase inhibitor\n* Treatment with moderate or strong CYP3A4 inducers within 14 days prior to initiation of study treatment\n* Treatment with moderate or strong CYP3A4 or P-glycoprotein inhibitors within 14 days prior to initiation of study treatment\n* Pregnancy, breastfeeding, or intention of becoming pregnant during the study\n\nAdditional Exclusion Criteria for the Combination with Bevacizumab Only:\n\n* Had major surgery within 4 weeks prior to study drug administration\n* Deep venous thrombosis (DVT) or pulmonary embolism (PE) within 12 weeks prior to study drug administration\n* Known coagulopathy that increases the risk of bleeding\n* Patients with Grade 2+ proteinuria (exception: if 24-hour urinary protein is less than 1.0 gm\u002F24 hours)\n\nAdditional Exclusion Criteria for the Combination with Pembrolizumab Only:\n\n* Active or history of autoimmune disease or immune deficiency with some exceptions\n* History of interstitial lung disease or pneumonitis\n* Treatment with systemic immunosuppressive medication (such as corticosteroids) within 2 weeks prior to initiation of study treatment with some exceptions\n* Treatment with organ transplant\u002Fgraft tissue","ALL","18 Years",{"count":19,"type":20},280,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of VVD-133214 monotherapy, and in combination with bevacizumab or pembrolizumab, in participants with microsatellite instability (MSI) and\u002For deficient mismatch repair (dMMR) advanced solid tumors. VVD-133214 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and\u002For dMMR. By acting on WRN, VVD-133214 may be able to block the growth of these types of cancer.",[26,27],"Advanced Solid Tumors","Colorectal Cancer",[29,30,31,32],"Deficient mismatch repair","dMMR","Microsatellite instability","MSI","RECRUITING","2026-08-13",{"date":36,"type":37},"2026-08-17","ACTUAL",{"date":39,"type":37},"2024-01-25",{"date":41,"type":20},"2027-05-31",{"name":43,"class":44},"Vividion Therapeutics, Inc.","INDUSTRY",43,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100512581","phase-1-a-first-in-human-fih-study-to-evaluate-the-safety-and-tolerability-of-vvd-130037-in-participants-with-advanced-solid-tumors-100512581","NCT05954312","A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors","A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of VVD-130037, a Kelch-like ECH Associated Protein 1 (KEAP1) Activator, in Participants With Advanced Solid Tumors","Key Inclusion Criteria for Parts 1 and 2:\n\n* Histologically or cytologically confirmed metastatic or unresectable solid tumor.\n* Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the Investigator.\n* Have progressed on or after all prior standard-of-care therapies for metastatic disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n* Adequate organ and marrow function as defined in the protocol.\n\nAdditional Key Inclusion Criteria for Part 2:\n\n* Participants with squamous non-small cell lung cancer (sqNSCLC) with or without nuclear factor erythroid 2-related factor 2 (NRF2 \\[NFE2L2\\]) and\u002For cullin 3 (CUL3) mutations.\n* Participants with advanced sqNSCLC must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor.\n* Participants with advanced head and neck squamous cell carcinoma (HNSCC) must have received prior treatment with platinum-based chemotherapy, an immune checkpoint inhibitor (for tumors with known programmed death-ligand 1 \\[PD-L1\\] expression, microsatellite instability-high, or mismatch repair deficiency, and an anti-epidermal growth factor receptor agent) (Combination Expansion Cohort).\n* Participants with advanced esophageal squamous cell carcinoma (ESCC) must have received prior treatment with platinum-based chemotherapy, an immune checkpoint inhibitor (for tumors with known PD-L1 expression) (Combination Expansion Cohort).\n* Participants with a known driver mutation, including activating epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, should have progressed after appropriate targeted treatment.\n* Participants with known human epidermal growth factor receptor 2 overexpression should have progressed after appropriate targeted treatment.\n\nKey Exclusion Criteria for Parts 1 and 2:\n\n* Participant is known to have a mutation that has no expectation of benefit from VVD-130037. Current such mutations include the following:\n\n  1. KEAP1 nonsense mutation (any position)\n  2. KEAP1 frameshift mutation (any position)\n* Any unresolved toxicity Grade ≥2 per CTCAE version 5.0 from previous anticancer treatment.\n* Current or prior treatment with anti-epileptic medications for the treatment or prophylaxis of seizures.\n* History of seizure or condition that may predispose to seizure.\n* History or presence of central nervous system (CNS) metastases or spinal cord compression.\n* Uncontrolled arterial hypertension despite optimal medical management.\n* Risk factors for abnormal heart rhythm\u002FQT prolongation as defined in the protocol.\n* History of the following cardiac diseases:\n\n  i) congestive heart failure (New York Heart Association \\[NYHA\\] Class \\>II), ii) unstable angina, iii) new onset angina within past 6 months, iv) myocardial Infarction within the past 6 months, v) clinically significant arrhythmias within past 6 months.\n* Any prior toxicity (Grade 3 or 4) related to immunotherapy leading to treatment discontinuation (Combination Expansion Cohort)\n* Medical history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD), drug induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active pneumonitis\u002FILD (Combination Expansion Cohort)",{"count":54,"type":20},290,[23],"A FIH dose escalation and dose expansion study to evaluate VVD-130037 in participants with advanced solid tumors as a single agent, and in combination with docetaxel, paclitaxel, or pembrolizumab.",[26],[59,60,61,62,63,64,65,66],"VVD-130037","First-in-Human","KEAP1","NRF2","Cancer","small molecule","squamous cell histology","esophageal adenocarcinoma","2026-05-06",{"date":69,"type":37},"2026-05-08",{"date":71,"type":37},"2023-07-28",{"date":73,"type":20},"2031-02-28",{"name":43,"class":44},26,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100577940","phase-1-a-first-in-human-fih-study-to-evaluate-the-safety-and-tolerability-of-vvd-159642-in-participants-with-advanced-solid-tumors-100577940","NCT06804824","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","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).",{"count":84,"type":20},220,[23],"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.",[26],[89,90,91,92,93,94,95,96],"RAS","PI3K","KRAS","MEK","Phase I","solid tumors","KRAS G12C","HER2","2026-03-16",{"date":99,"type":37},"2026-03-18",{"date":101,"type":37},"2025-02-25",{"date":103,"type":20},"2027-08-01",{"name":43,"class":44},9,""]