[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04665206":3,"trial-entities:NCT04665206":248,"trial-summary:NCT04665206":255},{"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":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":28,"interventions":31,"primary_outcomes":52,"secondary_outcomes":61,"sex":86,"minimum_age":87,"maximum_age":88,"healthy_volunteers":89,"eligibility_criteria":90,"std_ages":109,"locations":112,"central_contacts":232,"overall_officials":238,"references":242,"see_also_links":247},"NCT04665206","VT3989-001","Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors","Phase I\u002FII, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients With Locally Advanced or Metastatic Solid Tumors","RECRUITING","2030-03-02","2026-03","2026-04-02","2021-03-24","Vivace Therapeutics, Inc","INDUSTRY",true,"This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, and biological activity of VT3989 administered, alone or in combination, once daily in patients with mesothelioma and\u002For metastatic solid tumors that are resistant to standard therapy or for which no effective standard therapy is available.","Dose escalation (Part 1) will employ a traditional 3 + 3 design to assess safety of VT3989 in patients with metastatic solid tumors or mesothelioma. The 3 + 3 design will be implemented until the MTD or recommended phase 2 dose(s) and schedule(s) are determined. The MTD is defined as the highest dose level at which \\\u003C 33% of patients experience a dose limiting toxicity (DLT) during the first cycle of the study (Cycle 1).\n\nDose Expansion (Part 2) will further evaluate the safety and assess preliminary antitumor activity at the recommended phase 2 dose(s) and schedule(s) with up to 6 cohorts. Expansion cohorts 1 and 2 will enroll patients with mesothelioma of any site origin with or without NF2 mutations. Expansion cohort 3 will enroll non-pleural mesothelioma patients. Expansion cohort 4 will enroll solid tumor patients with clearly inactivating NF2 mutations\u002Falterations or YAP\u002FTAZ gene rearrangements. Cohort 5 will enroll pleural mesothelioma patients.\n\nCombination part (Part 3) includes three cohorts. Cohort A will enroll mesothelioma patients who will receive VT3989 in combination with immunotherapy (nivolumab plus ipilimumab). Cohort B will enroll NSCLC patients whose tumors have exon 19 deletion or exon 21 L858R mutation and will receive VT3989 in combination with targeted therapy (Osimertinib). Cohort C will enroll mesothelioma patients who will receive VT3989 in combination with chemotherapy (pemetrexed plus carboplatin).",[19,20,21],"Solid Tumor, Adult","Mesothelioma","NSCLC",[],"INTERVENTIONAL","TREATMENT",[26,27],"PHASE1","PHASE2",{"count":29,"type":30},434,"ESTIMATED",[32,40,44,48],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","VT3989","25, 50, 100, 150 or 200 mg capsules for oral administration.",[37,38,39],"Combination [Recruiting]","Dose Expansion [Not Recruiting]","VT3989 Dose Escalation [Not Recruiting]",{"type":33,"name":41,"description":42,"armGroupLabels":43},"Nivolumab & Ipilimumab","Nivolumab infusion - 360 mg every 3 weeks, 30-minute intravenous infusion\n\nIpilimumab infusion - 1 mg\u002Fkg every 6 weeks, 30-minute intravenous infusion",[37],{"type":33,"name":45,"description":46,"armGroupLabels":47},"Osimertinib","40 or 80 mg tablets for oral administration",[37],{"type":33,"name":49,"description":50,"armGroupLabels":51},"Pemetrexed\u002FCarboplatin","Pemetrexed infusion: 500 mg\u002Fm2 intravenous infusion Carboplatin infusion: AUC 5.0 intravenous infusion",[37],[53,57],{"measure":54,"description":55,"timeFrame":56},"Occurrence of Dose Limiting Toxicity","Incidence of Adverse and Serious Adverse Events","over the first 21 days of dosing",{"measure":58,"description":59,"timeFrame":60},"Occurrence of General Toxicity","Incidence of Adverse and Serious Adverse Events, Discontinuations due to Adverse Events and general safety evaluations","through study completion, an average of 30 months",[62,65,69,72,75,79,82],{"measure":63,"description":64,"timeFrame":60},"Tumor Response","Determined by RECIST v1.1 or modified RECIST v1.1",{"measure":66,"description":67,"timeFrame":68},"Pharmacokinetic Evaluation - Cmax","Peak plasma concentration of VT3989","for first 6 cycles",{"measure":70,"description":71,"timeFrame":68},"Pharmacokinetic Evaluation - Tmax","Time to reach peak plasma concentration of VT3989",{"measure":73,"description":74,"timeFrame":68},"Pharmacokinetic Evaluation - Half-life","Time required for the plasma concentration of VT3989 to reduce by half after reaching peak",{"measure":76,"description":77,"timeFrame":78},"Overall survival","The overall survival of the enrolled patients from starting VT3989 treatment","At 6, 12, 18 and 24 months",{"measure":80,"description":81,"timeFrame":78},"Progression free survival","The progression free survival of the enrolled patients from starting VT3989 treatment",{"measure":83,"description":84,"timeFrame":85},"Quality of life assessment (Part 2, expansion cohort 3, 4, and 5)","Assessing the Quality of life changes via patient reported outcomes","Through study completion, an average of 30 months","ALL","18 Years",null,false,{"inclusion":91,"exclusion":98,"raw_text":108},[92,93,94,95,96,97],"Part 3 Combination Cohort A: Patients with pathologically diagnosed, metastatic or unresectable malignant mesothelioma (including both pleural and non-pleural) who have not received systemic therapy.","Part 3 Combination Cohort B: Patients with pathologically diagnosed incurable locally advanced (inoperable or recurrent), or metastatic NSCLC with exon 19 deletions or exon 21 L858R mutations, with or without prior treatment with Osimertinib.","Part 3 Combination Cohort C: Patients with pathologically diagnosed metastatic or unresectable malignant pleural mesothelioma who have not received systemic chemotherapy.","Measurable disease per RECIST v1.1 for non-pleural mesothelioma or other solid tumors or modified RECIST v1.1 for malignant pleural mesothelioma. mRECIST may be used for pleural extension of non-pleural mesothelioma or for mixed pleural and peritoneal (or other) mesothelioma.","ECOG: 0-1.","Adequate organ functions, including the liver, kidneys, and hematopoietic system.",[99,100,101,102,103,104,105,106,107],"Active brain metastases or primary CNS (central nervous system) tumors.","History of leptomeningeal metastases","Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy","Known HIV positive or active Hepatitis B or Hepatitis C","Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents.","Corrected QT (QTcF) interval \\> 470 msec (using Fridericia's correction formula).","Additional active malignancy that may confound the assessment of the study endpoints","Women who are pregnant or breastfeeding","Prior treatment with TEAD inhibitor.","Inclusion Criteria:\n\n* Part 3 Combination Cohort A: Patients with pathologically diagnosed, metastatic or unresectable malignant mesothelioma (including both pleural and non-pleural) who have not received systemic therapy.\n* Part 3 Combination Cohort B: Patients with pathologically diagnosed incurable locally advanced (inoperable or recurrent), or metastatic NSCLC with exon 19 deletions or exon 21 L858R mutations, with or without prior treatment with Osimertinib.\n* Part 3 Combination Cohort C: Patients with pathologically diagnosed metastatic or unresectable malignant pleural mesothelioma who have not received systemic chemotherapy.\n* Measurable disease per RECIST v1.1 for non-pleural mesothelioma or other solid tumors or modified RECIST v1.1 for malignant pleural mesothelioma. mRECIST may be used for pleural extension of non-pleural mesothelioma or for mixed pleural and peritoneal (or other) mesothelioma.\n* ECOG: 0-1.\n* Adequate organ functions, including the liver, kidneys, and hematopoietic system.\n\nExclusion Criteria:\n\n* Active brain metastases or primary CNS (central nervous system) tumors.\n* History of leptomeningeal metastases\n* Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy\n* Known HIV positive or active Hepatitis B or Hepatitis C\n* Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents.\n* Corrected QT (QTcF) interval \\> 470 msec (using Fridericia's correction formula).\n* Additional active malignancy that may confound the assessment of the study endpoints\n* Women who are pregnant or breastfeeding\n* Prior treatment with TEAD inhibitor.",[110,111],"ADULT","OLDER_ADULT",[113,128,138,148,154,164,173,183,192,202,213,222],{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":118,"contacts":119,"geoPoint":125},"UCSF Helen Diller Family Comprehensive Cancer Center","San Francisco","California","94158","United States",[120],{"name":121,"role":122,"phone":123,"email":124},"Heather Fritz","CONTACT","650-627-7437","hfritz@inclin.com",{"lat":126,"lon":127},37.77493,-122.41942,{"facility":129,"status":8,"city":130,"state":131,"zip":132,"country":118,"contacts":133,"geoPoint":135},"University of Chicago Medical Center","Chicago","Illinois","60637",[134],{"name":121,"role":122,"phone":123,"email":124},{"lat":136,"lon":137},41.85003,-87.65005,{"facility":139,"status":8,"city":140,"state":141,"zip":142,"country":118,"contacts":143,"geoPoint":145},"Massachusetts General Hospital","Boston","Massachusetts","02114",[144],{"name":121,"role":122,"phone":123,"email":124},{"lat":146,"lon":147},42.35843,-71.05977,{"facility":149,"status":8,"city":140,"state":141,"zip":150,"country":118,"contacts":151,"geoPoint":153},"Dana-Farber Cancer Institute","02215",[152],{"name":121,"role":122,"phone":123,"email":124},{"lat":146,"lon":147},{"facility":155,"status":8,"city":156,"state":157,"zip":158,"country":118,"contacts":159,"geoPoint":161},"M Health Fairview University of Minnesota Medical Center","Minneapolis","Minnesota","55455",[160],{"name":121,"role":122,"phone":123,"email":124},{"lat":162,"lon":163},44.97997,-93.26384,{"facility":165,"status":8,"city":166,"state":166,"zip":167,"country":118,"contacts":168,"geoPoint":170},"Memorial Sloan Kettering Cancer Center","New York","10065",[169],{"name":121,"role":122,"phone":123,"email":124},{"lat":171,"lon":172},40.71427,-74.00597,{"facility":174,"status":8,"city":175,"state":176,"zip":177,"country":118,"contacts":178,"geoPoint":180},"MD Anderson Cancer Center","Houston","Texas","77030",[179],{"name":121,"role":122,"phone":123,"email":124},{"lat":181,"lon":182},29.76328,-95.36327,{"facility":184,"status":8,"city":185,"state":176,"zip":186,"country":118,"contacts":187,"geoPoint":189},"NEXT Oncology","San Antonio","78229",[188],{"name":121,"role":122,"phone":123,"email":124},{"lat":190,"lon":191},29.42412,-98.49363,{"facility":193,"status":8,"city":194,"state":195,"zip":196,"country":118,"contacts":197,"geoPoint":199},"Virginia Cancer Specialists, PC","Arlington","Virginia","22201",[198],{"name":121,"role":122,"phone":123,"email":124},{"lat":200,"lon":201},38.88101,-77.10428,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":207,"contacts":208,"geoPoint":210},"Monash Health","Clayton","Victoria","3168","Australia",[209],{"name":121,"role":122,"phone":123,"email":124},{"lat":211,"lon":212},-37.91667,145.11667,{"facility":214,"status":8,"city":215,"state":205,"zip":216,"country":207,"contacts":217,"geoPoint":219},"Peter MacCullum Cancer Centre","Melbourne","3000",[218],{"name":121,"role":122,"phone":123,"email":124},{"lat":220,"lon":221},-37.814,144.96332,{"facility":223,"status":8,"city":224,"state":225,"zip":226,"country":207,"contacts":227,"geoPoint":229},"Linear Clinical Research","Nedlands","Western Australia","6009",[228],{"name":121,"role":122,"phone":123,"email":124},{"lat":230,"lon":231},-31.98184,115.8073,[233,234],{"name":121,"role":122,"phone":123,"email":124},{"name":235,"role":122,"phone":236,"email":237},"Neelesh Sharma, MD","732-476-4978","nsharma@vivacetherapeutics.com",[239],{"name":235,"affiliation":240,"role":241},"Vivace Therapeutics","STUDY_DIRECTOR",[243],{"pmid":244,"type":245,"citation":246},"41111090","DERIVED","Yap TA, Kwiatkowski DJ, Dagogo-Jack I, Offin M, Zauderer MG, Kratzke R, Desai J, Body A, Millward M, Tolcher AW, Raghav KPS, Thurston A, Post L, Dorr FA, Tang TT, Li Y, Sharma N, Kindler HL. YAP\u002FTEAD inhibitor VT3989 in solid tumors: a phase 1\u002F2 trial. Nat Med. 2025 Dec;31(12):4281-4290. doi: 10.1038\u002Fs41591-025-04029-3. Epub 2025 Oct 19.",[],{"nct_id":4,"conditions":249,"biomarkers":253},[250,251,252],"Lung Non-Small Cell Carcinoma","Mesothelial Neoplasm","Solid Neoplasm",[254],"Soluble Epidermal Growth Factor Receptor",{"nct_id":4,"found":15,"summary":256,"prompt_version":266},{"design":257,"status":258,"heading":259,"summary":260,"follow_up":261,"word_count":262,"commitments":263,"compensation":264,"drugs_mentioned":265},"This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It involves different parts, including dose escalation to find the best dose and dose expansion to further evaluate safety and preliminary anti-tumor activity.","completed","VT3989 for Metastatic Solid Tumors and Mesothelioma","This study is testing a new drug called VT3989, alone or with other treatments like Nivolumab & Ipilimumab, Osimertinib, or Pemetrexed\u002FCarboplatin. It's for adults with metastatic solid tumors (cancers that have spread) or mesothelioma (a type of cancer that forms in the lining of the lungs, abdomen, or heart). The main goals are to understand the safety of VT3989 and see how well it's tolerated, especially looking for any serious side effects in the first 21 days and throughout the study. This study is open to adults aged 18 and older. The current status of this study is unclear, and it plans to enroll 434 participants.","General toxicity will be measured through study completion, which is an average of 30 months.",106,"Not specified in the trial record.","Not stated in the trial record.",[34,41,45,49],"v2"]