[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04485013":3,"trial-entities:NCT04485013":491,"trial-summary:NCT04485013":496},{"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":47,"primary_purpose":48,"phases":49,"enrollment_info":51,"interventions":54,"primary_outcomes":88,"secondary_outcomes":92,"sex":111,"minimum_age":112,"maximum_age":113,"healthy_volunteers":15,"eligibility_criteria":114,"std_ages":118,"locations":121,"central_contacts":483,"overall_officials":488,"references":489,"see_also_links":490},"NCT04485013","TTX-080-001","TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers","A Phase 1a\u002F1b Dose Escalation\u002FExpansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients With Advanced Solid Refractory\u002FResistant Malignancies","RECRUITING","2027-06-01","2025-12","2026-02-18","2020-07-14","Tizona Therapeutics, Inc","INDUSTRY",false,"TTX-080-001 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor), cetuximab (EGFR inhibitor) or FOLFIRI plus cetuximab (EGFR inhibitor) in patients with advanced refractory \u002F resistant solid malignancies including metastatic colorectal cancer (mCRC) patients.","TTX-080 is a fully human mAb designed to block the interaction of HLA-G with its known ligands, ILT2 and ILT4 molecules. The Phase 1a was an open label, multicenter, dose escalation clinical trial to determine the safety, tolerability, MTD or OBD, and the RP2D of TTX-080 when administered as a single agent. The Phase 1b is a dose expansion of TTX-080 monotherapy and in combination with either pembrolizumab or cetuximab in adult subjects with advanced refractory\u002Fresistant solid malignancies, including Head and Neck squamous cell carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Colorectal cancer (CRC), triple negative breast cancer (TNBC), renal cell carcinoma (RCC), and acral melanoma. Additionally, the Phase 1b includes randomized arms with TTX-080 in combination with FOLFIRI plus cetuximab compared to FOLFIRI plus cetuximab in metastatic Colorectal cancer. The study will seek to evaluate the pharmacokinetics and immunogenicity of TTX-080, and characterize the anti-tumor activity of TTX-080 as a monotherapy and in combination with pembrolizumab, cetuximab or FOLFIRI plus cetuximab. Only arm 9 and 10 are currently open to enrollment.",[19],"Cancer",[21,22,23,19,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"HLA-G","TTX-080","Advanced Solid Tumor","Ovarian Cancer","Endometrial Cancer","Cervical Cancer","Kidney Cancer","Head and Neck Squamous Cell Carcinoma","Squamous Cell Lung Cancer","Prostate Cancer","Colorectal Cancer","Gastric Cancer","Breast Cancer","Bladder Cancer","Lung Adenocarcinoma","Melanoma","Metastatic Solid Tumor","Renal cell carcinoma","Acral melanoma","Triple Negative Breast Cancer","Pembrolizumab","Cetuximab","Antineoplastic Agents, Immunological","Antineoplastic Agents","Head and Neck Cancer","Lung Cancer","INTERVENTIONAL","TREATMENT",[50],"PHASE1",{"count":52,"type":53},240,"ESTIMATED",[55,60,71,74,78,84,86],{"type":56,"name":22,"description":57,"armGroupLabels":58},"DRUG","Variable dose (Q3W)",[59],"Phase 1a, Monotherapy Dose Escalation",{"type":56,"name":22,"description":61,"armGroupLabels":62},"Specified dose (Q3W)",[63,64,65,66,67,68,69,70],"Phase 1b, Dose Expansion: TTX-080 as monotherapy OR in combination with pembrolizumab","Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), no prior anti-EGFR therapy","Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), prior anti-EGFR therapy","Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (HNSCC)","Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (HNSCC)","Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (NSCLC)","Phase 1b, Dose Expansion: TTX-080 monotherapy (CRC)","Phase 1b, Dose Expansion: TTX-080 monotherapy (NSCLC)",{"type":56,"name":72,"description":61,"armGroupLabels":73},"pembrolizumab",[63,67,68],{"type":56,"name":75,"description":76,"armGroupLabels":77},"cetuximab","Specified dose on specified days",[64,65,66],{"type":56,"name":79,"description":80,"armGroupLabels":81},"FOLFIRI","Specified dose (Q2W)",[82,83],"FOLFIRI plus cetuximab","TTX-080 in combination with FOLFIRI plus cetuximab",{"type":56,"name":75,"description":80,"armGroupLabels":85},[82,83],{"type":56,"name":22,"description":80,"armGroupLabels":87},[83],[89],{"measure":90,"timeFrame":91},"1. To determine the anti-tumor activity of TTX-080 by objective response rate [complete response + partial response) for each tumor arm per RECIST 1.1","Up to 48 months",[93,95,97,99,101,103,105,107,109],{"measure":94,"timeFrame":91},"Duration of Response, Progression Free Survival per RECIST 1.1",{"measure":96,"timeFrame":91},"Overall Survival",{"measure":98,"timeFrame":91},"Adverse events (AEs) as characterized by the incidence, type, frequency, severity (graded according to NCI-CTCAE v5.0), timing, seriousness, and relationship to investigational product, and\u002For combination therapy, and\u002For individual approved therapies",{"measure":100,"timeFrame":91},"Tolerability: The number of cycles of TTX-080 received by patients before discontinuing due to unmanageable drug reactions",{"measure":102,"timeFrame":91},"Serum levels of Anti Drug Antibody against TTX-080",{"measure":104,"timeFrame":91},"Cmax: Maximum Observed Plasma Concentration for TTX-080",{"measure":106,"timeFrame":91},"Tmax: Time to Reach the Cmax for TTX-080",{"measure":108,"timeFrame":91},"AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for TTX-080",{"measure":110,"timeFrame":91},"AUC(0-Inf): Area Under the Plasma Concentration-time Curve From Zero to Infinity for TTX-080","ALL","18 Years",null,{"inclusion":115,"exclusion":116,"raw_text":117},[],[],"Abbreviated Inclusion Criteria:\n\n1. Subject with histological diagnosis of advanced\u002Fmetastatic cancer \\[currently enrolling in CRC only\\]\n2. Age 18 years or older, is willing and able to provide informed consent\n3. Evidence of measurable disease\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 AND life expectancy of at least 12 weeks\n\nAbbreviated Exclusion Criteria:\n\n1. History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody\n2. Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study\n3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy\n4. History of severe autoimmune disease\n5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment",[119,120],"ADULT","OLDER_ADULT",[122,132,140,147,159,167,175,183,194,200,210,217,225,232,240,248,260,270,278,289,300,308,319,330,337,344,355,362,369,381,389,397,408,412,423,433,440,450,457,468,476],{"facility":123,"status":124,"city":125,"state":126,"zip":127,"country":128,"geoPoint":129},"Arizona Oncology Associates","COMPLETED","Tucson","Arizona","85711","United States",{"lat":130,"lon":131},32.22174,-110.92648,{"facility":133,"status":124,"city":134,"state":135,"zip":136,"country":128,"geoPoint":137},"University of Southern California","Los Angeles","California","90033",{"lat":138,"lon":139},34.05223,-118.24368,{"facility":141,"status":124,"city":142,"state":135,"zip":143,"country":128,"geoPoint":144},"Hoag Memorial Hospital","Newport Beach","92663",{"lat":145,"lon":146},33.61891,-117.92895,{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":128,"contacts":152,"geoPoint":156},"Rocky Mountain Cancer Centers","Denver","Colorado","80218",[153],{"role":154,"phone":155},"CONTACT","303-388-4876",{"lat":157,"lon":158},39.73915,-104.9847,{"facility":160,"status":124,"city":161,"state":162,"zip":163,"country":128,"geoPoint":164},"Yale Cancer Center","New Haven","Connecticut","06511",{"lat":165,"lon":166},41.30815,-72.92816,{"facility":168,"status":124,"city":169,"state":170,"zip":171,"country":128,"geoPoint":172},"Christiana Care Helen F. Graham Cancer Center","Newark","Delaware","19713",{"lat":173,"lon":174},39.68372,-75.74966,{"facility":176,"status":124,"city":177,"state":178,"zip":179,"country":128,"geoPoint":180},"John Hopkins Kimmer Cancer Center","Washington D.C.","District of Columbia","20016",{"lat":181,"lon":182},38.89511,-77.03637,{"facility":184,"status":8,"city":185,"state":186,"zip":187,"country":128,"contacts":188,"geoPoint":191},"Florida Cancer Specialists","Daytona Beach","Florida","32117",[189],{"role":154,"phone":190},"386-231-4060",{"lat":192,"lon":193},29.21081,-81.02283,{"facility":184,"status":124,"city":195,"state":186,"zip":196,"country":128,"geoPoint":197},"Fleming Island","32003",{"lat":198,"lon":199},30.0933,-81.71898,{"facility":201,"status":8,"city":202,"state":186,"zip":203,"country":128,"contacts":204,"geoPoint":207},"Ocala Oncology Center","Ocala","34474",[205],{"role":154,"phone":206},"352-547-1958",{"lat":208,"lon":209},29.1872,-82.14009,{"facility":211,"status":124,"city":212,"state":186,"zip":213,"country":128,"geoPoint":214},"AdventHealth Research Institute","Orlando","32804",{"lat":215,"lon":216},28.53834,-81.37924,{"facility":218,"status":124,"city":219,"state":220,"zip":221,"country":128,"geoPoint":222},"Illinois Cancer Specialists","Arlington Heights","Illinois","60005",{"lat":223,"lon":224},42.08836,-87.98063,{"facility":226,"status":124,"city":227,"state":220,"zip":228,"country":128,"geoPoint":229},"University of Illinois","Chicago","60612",{"lat":230,"lon":231},41.85003,-87.65005,{"facility":233,"status":124,"city":234,"state":235,"zip":236,"country":128,"geoPoint":237},"Indiana University","Indianapolis","Indiana","46202",{"lat":238,"lon":239},39.76838,-86.15804,{"facility":241,"status":124,"city":242,"state":243,"zip":244,"country":128,"geoPoint":245},"Norton Cancer Institute","Louisville","Kentucky","40241",{"lat":246,"lon":247},38.25424,-85.75941,{"facility":249,"status":8,"city":250,"state":251,"zip":252,"country":128,"contacts":253,"geoPoint":257},"American Oncology Partners, P.A. - The Center for Cancer & Blood Disorders","Bethesda","Maryland","20817",[254],{"role":154,"phone":255,"phoneExt":256},"301-571-2016","2110",{"lat":258,"lon":259},38.98067,-77.10026,{"facility":261,"status":8,"city":262,"state":251,"zip":263,"country":128,"contacts":264,"geoPoint":267},"Maryland Oncology Hematology","Silver Spring","20904",[265],{"role":154,"phone":266},"301-933-3216",{"lat":268,"lon":269},38.99067,-77.02609,{"facility":271,"status":124,"city":272,"state":273,"zip":274,"country":128,"geoPoint":275},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",{"lat":276,"lon":277},42.35843,-71.05977,{"facility":279,"status":8,"city":280,"state":281,"zip":282,"country":128,"contacts":283,"geoPoint":286},"START Midwest","Grand Rapids","Michigan","49546",[284],{"role":154,"phone":285},"616-954-5554",{"lat":287,"lon":288},42.96336,-85.66809,{"facility":290,"status":8,"city":291,"state":292,"zip":293,"country":128,"contacts":294,"geoPoint":297},"Regions Hospital Cancer Care Center","Saint Paul","Minnesota","55101",[295],{"role":154,"phone":296},"651-254-3602",{"lat":298,"lon":299},44.94441,-93.09327,{"facility":301,"status":124,"city":302,"state":303,"zip":304,"country":128,"geoPoint":305},"Washington University in St Louis","St Louis","Missouri","63110",{"lat":306,"lon":307},38.62727,-90.19789,{"facility":309,"status":8,"city":310,"state":311,"zip":312,"country":128,"contacts":313,"geoPoint":316},"Nebraska Cancer Center Oncology Hematology West P.C.","Omaha","Nebraska","68130",[314],{"role":154,"phone":315},"402-691-6971",{"lat":317,"lon":318},41.25626,-95.94043,{"facility":320,"status":8,"city":321,"state":322,"zip":323,"country":128,"contacts":324,"geoPoint":327},"Rutgers Cancer Institute of New Jersey","New Brunswick","New Jersey","08903",[325],{"role":154,"phone":326},"732-235-3253",{"lat":328,"lon":329},40.48622,-74.45182,{"facility":331,"status":124,"city":332,"state":332,"zip":333,"country":128,"geoPoint":334},"Icahn School of Medicine at Mount Sinai","New York","10029",{"lat":335,"lon":336},40.71427,-74.00597,{"facility":338,"status":124,"city":339,"state":332,"zip":340,"country":128,"geoPoint":341},"Stony Brook University","Stony Brook","11794",{"lat":342,"lon":343},40.92565,-73.14094,{"facility":345,"status":8,"city":346,"state":347,"zip":348,"country":128,"contacts":349,"geoPoint":352},"University of Cincinnati","Cincinnati","Ohio","45267",[350],{"role":154,"phone":351},"513-584-5680",{"lat":353,"lon":354},39.12711,-84.51439,{"facility":356,"status":124,"city":357,"state":347,"zip":358,"country":128,"geoPoint":359},"Zangmeister Cancer Center","Columbus","43219",{"lat":360,"lon":361},39.96118,-82.99879,{"facility":363,"status":124,"city":364,"state":347,"zip":365,"country":128,"geoPoint":366},"The University of Toledo","Toledo","43606",{"lat":367,"lon":368},41.66394,-83.55521,{"facility":370,"status":8,"city":371,"state":372,"zip":373,"country":128,"contacts":374,"geoPoint":378},"University of Oklahoma","Oklahoma City","Oklahoma","73104",[375],{"role":154,"phone":376,"phoneExt":377},"405-271-8001","32084",{"lat":379,"lon":380},35.46756,-97.51643,{"facility":382,"status":124,"city":383,"state":384,"zip":385,"country":128,"geoPoint":386},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15232",{"lat":387,"lon":388},40.44062,-79.99589,{"facility":390,"status":124,"city":391,"state":392,"zip":393,"country":128,"geoPoint":394},"Medical University of South Carolina","Charleston","South Carolina","29425",{"lat":395,"lon":396},32.77632,-79.93275,{"facility":398,"status":8,"city":399,"state":400,"zip":401,"country":128,"contacts":402,"geoPoint":405},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",[403],{"role":154,"phone":404},"615-524-4203",{"lat":406,"lon":407},36.16589,-86.78444,{"facility":409,"status":124,"city":399,"state":400,"zip":410,"country":128,"geoPoint":411},"Vanderbilt - Ingram Cancer Center","37232",{"lat":406,"lon":407},{"facility":413,"status":8,"city":414,"state":415,"zip":416,"country":128,"contacts":417,"geoPoint":420},"Texas Oncology - Dallas","Dallas","Texas","75246",[418],{"role":154,"phone":419},"214-370-1000",{"lat":421,"lon":422},32.78306,-96.80667,{"facility":424,"status":8,"city":425,"state":415,"zip":426,"country":128,"contacts":427,"geoPoint":430},"START Dallas","Fort Worth","76104",[428],{"role":154,"phone":429},"682-350-3010",{"lat":431,"lon":432},32.72541,-97.32085,{"facility":434,"status":124,"city":435,"state":415,"zip":436,"country":128,"geoPoint":437},"The University of Texas MD Anderson Cancer Center","Houston","77030",{"lat":438,"lon":439},29.76328,-95.36327,{"facility":441,"status":8,"city":442,"state":415,"zip":443,"country":128,"contacts":444,"geoPoint":447},"Texas Oncology - Paris","Paris","75460",[445],{"role":154,"phone":446},"903-785-0031",{"lat":448,"lon":449},33.66094,-95.55551,{"facility":451,"status":124,"city":452,"state":415,"zip":453,"country":128,"geoPoint":454},"NEXT Oncology","San Antonio","78229",{"lat":455,"lon":456},29.42412,-98.49363,{"facility":458,"status":8,"city":459,"state":460,"zip":461,"country":128,"contacts":462,"geoPoint":465},"NEXT Oncology Virginia","Fairfax","Virginia","22031",[463],{"role":154,"phone":464},"703-280-5290",{"lat":466,"lon":467},38.84622,-77.30637,{"facility":469,"status":124,"city":470,"state":471,"zip":472,"country":128,"geoPoint":473},"Northwest Medical Specialties","Tacoma","Washington","98405",{"lat":474,"lon":475},47.25288,-122.44429,{"facility":477,"status":124,"city":478,"state":471,"zip":479,"country":128,"geoPoint":480},"Northwest Cancer Specialists","Vancouver","98684",{"lat":481,"lon":482},45.63873,-122.66149,[484],{"name":485,"role":154,"phone":486,"email":487},"Tizona Therapeutics, Inc.","888-585-2990","clinicaltrials@tizonatx.com",[],[],[],{"nct_id":4,"conditions":492,"biomarkers":495},[493,494],"Colorectal Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":497,"summary":498,"prompt_version":508},true,{"design":499,"status":500,"heading":501,"summary":502,"follow_up":503,"word_count":504,"commitments":505,"compensation":506,"drugs_mentioned":507},"This is a Phase 1, open-label (meaning you and your doctors will know what treatment you are receiving) study. It is testing different doses of TTX-080 alone and in combination with other drugs.","completed","TTX-080 for Advanced Cancers","This study is testing a drug called TTX-080, alone or with other approved cancer treatments like pembrolizumab, cetuximab, or FOLFIRI, for people with advanced cancers. TTX-080 is a monoclonal antibody (a type of immune therapy) that blocks HLA-G, which may help the immune system fight cancer. The study aims to see how well TTX-080 works by measuring tumor shrinkage (objective response rate). Currently, only people with advanced colorectal cancer can join. You might be eligible if you are 18 or older, have measurable cancer, and a good performance status. The study plans to enroll 240 participants.","The study will measure how well the treatment works for up to 48 months.",96,"Not specified in the trial record.","Not stated in the trial record.",[22,72,75,79],"v2"]