[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06657222":3,"trial-entities:NCT06657222":225,"trial-summary:NCT06657222":234},{"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":25,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":32,"interventions":35,"primary_outcomes":43,"secondary_outcomes":48,"sex":73,"minimum_age":74,"maximum_age":17,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":80,"locations":83,"central_contacts":213,"overall_officials":219,"references":223,"see_also_links":224},"NCT06657222","5-STAR 1-01","First in Human Study of TUB-030 in Patients With Advanced Solid Tumors","A Multicenter FIH Dose Escalation and Optimization Phase I\u002FIIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)","RECRUITING","2028-12","2026-08","2026-08-14","2024-12-13","Tubulis GmbH","INDUSTRY",true,"The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are:\n\nTo determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose.\n\nParticipants will:\n\nReceive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms",null,[19,20,21,22,23,24],"Advanced Solid Tumors","HNSCC","SCLC","NSCLC","TNBC - Triple-Negative Breast Cancer","CRC",[19,22,26],"Head and Neck Cancer","INTERVENTIONAL","TREATMENT",[30,31],"PHASE1","PHASE2",{"count":33,"type":34},250,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DRUG","TUB-030","A complete treatment cycle is defined as 21 calendar days. TUB-030 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle",[41,42],"Phase 1: dose escalation","Phase 2: dose optimization in NSCLC and HNSCC",[44],{"measure":45,"description":46,"timeFrame":47},"Determination of MTD","The highest dose is defined at which no more than 1 of 3 patients have had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria","From enrollment until 30 days after last study drug",[49,52,55,58,61,64,66,69],{"measure":50,"description":51,"timeFrame":47},"Number of patients with Adverse Events (AE)","Any medical event in a participant which may or may not have a causal relationship with this treatment.",{"measure":53,"description":54,"timeFrame":47},"Maximum concentration (Cmax)","The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Cmax will be derived).",{"measure":56,"description":57,"timeFrame":47},"Trough concentration (Cmin)","The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Cmin will be derived).",{"measure":59,"description":60,"timeFrame":47},"The time taken to reach the maximum concentration (Tmax)","The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Tmax will be derived).",{"measure":62,"description":63,"timeFrame":47},"Area Under Curve (AUC)","PK endpoint",{"measure":65,"description":63,"timeFrame":47},"Half life (T1\u002F2)",{"measure":67,"description":68,"timeFrame":47},"Determination of immunogenicity","Number and percentage of patients developing anti-TUB-030 antibodies",{"measure":70,"description":71,"timeFrame":72},"Determination of efficacy","ORR by investigator assest Recist 1.1","From enrolment until 30 days after last study drug.","ALL","18 Years",false,{"inclusion":77,"exclusion":78,"raw_text":79},[],[],"Inclusion Criteria:\n\n1. Male or non-pregnant, non-breastfeeding female aged 18 years or older\n2. Adequate organ function\n3. Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1\n4. AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.\n5. For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.\n6. For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D1. For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D1.\n7. Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.\n8. Eastern Cooperative Oncology Group (ECOG) 0-1.\n9. Have a life expectancy of \\>12 weeks for disease-related mortality, as evaluated by the INV.\n10. In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent\n11. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.\n12. Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n\\-",[81,82],"ADULT","OLDER_ADULT",[84,93,101,109,113,121,129,136,144,151,159,166,173,181,188,195,200,207],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Yale Cancer Center","New Haven","Connecticut","06510","United States",{"lat":91,"lon":92},41.30815,-72.92816,{"facility":94,"status":8,"city":95,"state":96,"zip":97,"country":89,"geoPoint":98},"University of Miami","Miami","Florida","33136",{"lat":99,"lon":100},25.77427,-80.19366,{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":89,"geoPoint":106},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":107,"lon":108},42.35843,-71.05977,{"facility":110,"status":8,"city":103,"state":104,"zip":111,"country":89,"geoPoint":112},"Dana Farber Cancer Institute","02215",{"lat":107,"lon":108},{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":89,"geoPoint":118},"Mayo Clinic","Rochester","Minnesota","55905",{"lat":119,"lon":120},44.02163,-92.4699,{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":89,"geoPoint":126},"Washington University","St Louis","Missouri","63130",{"lat":127,"lon":128},38.62727,-90.19789,{"facility":130,"status":8,"city":131,"state":131,"zip":132,"country":89,"geoPoint":133},"Mount Sinai","New York","11766",{"lat":134,"lon":135},40.71427,-74.00597,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":89,"geoPoint":141},"Cleveland Clinic","Cleveland","Ohio","44195",{"lat":142,"lon":143},41.4995,-81.69541,{"facility":145,"status":8,"city":146,"state":139,"zip":147,"country":89,"geoPoint":148},"Ohio State University","Columbus","43210",{"lat":149,"lon":150},39.96118,-82.99879,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":89,"geoPoint":156},"NEXT Oncology Austin","Austin","Texas","78758",{"lat":157,"lon":158},30.26715,-97.74306,{"facility":160,"status":8,"city":161,"state":154,"zip":162,"country":89,"geoPoint":163},"NEXT Oncology - Dallas","Irving","75039",{"lat":164,"lon":165},32.81402,-96.94889,{"facility":167,"status":8,"city":168,"state":154,"zip":169,"country":89,"geoPoint":170},"NEXT Oncology - San Antonio","San Antonio","78229",{"lat":171,"lon":172},29.42412,-98.49363,{"facility":174,"status":8,"city":175,"state":176,"zip":177,"country":89,"geoPoint":178},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"lat":179,"lon":180},47.60621,-122.33207,{"facility":182,"status":8,"city":183,"country":184,"geoPoint":185},"Princess Margaret","Toronto","Canada",{"lat":186,"lon":187},43.70643,-79.39864,{"facility":189,"status":8,"city":190,"country":191,"geoPoint":192},"Arensia Exploratory Medicine","Bucharest","Romania",{"lat":193,"lon":194},44.43225,26.10626,{"facility":189,"status":8,"city":196,"country":191,"geoPoint":197},"Cluj-Napoca",{"lat":198,"lon":199},46.76667,23.6,{"facility":201,"status":8,"city":202,"country":203,"geoPoint":204},"Hospital Clinic Barcelona","Barcelona","Spain",{"lat":205,"lon":206},41.38879,2.15899,{"facility":208,"status":8,"city":209,"country":203,"geoPoint":210},"Clinica Uni de Navara","Madrid",{"lat":211,"lon":212},40.4165,-3.70256,[214],{"name":215,"role":216,"phone":217,"email":218},"Tubulis Clinical Trial Inquiries","CONTACT","+491758005594","ct-inquiries@tubulis.com",[220],{"name":221,"affiliation":13,"role":222},"Yariv Houvras, MD, PhD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":226,"biomarkers":233},[227,228,229,230,231,232],"Colorectal Carcinoma","Lung Non-Small Cell Carcinoma","Lung Small Cell Carcinoma","Malignant Head and Neck Neoplasm","Solid Neoplasm","Triple-Negative Breast Carcinoma",[],{"nct_id":4,"found":15,"summary":235,"prompt_version":17},{"design":236,"status":237,"heading":238,"summary":239,"follow_up":240,"word_count":241,"commitments":242,"compensation":243,"drugs_mentioned":244},"This is an interventional study, meaning participants will receive the drug TUB-030. It aims to enroll 250 participants.","completed","Study of TUB-030 for Advanced Solid Tumors","This study is testing a new drug called TUB-030 for adults with advanced solid tumors, including head and neck cancer (HNSCC), small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), and triple-negative breast cancer (TNBC). The main goals are to find out how safe TUB-030 is, what side effects it might cause, and the highest dose that can be given safely (maximum tolerated dose or MTD). Researchers will also see if TUB-030 works to treat these cancers. You might be able to join if you are 18 or older, have good organ function, and have waited a certain time after your last cancer treatment. This trial is looking to enroll about 250 participants.","Your safety will be monitored from enrollment until 30 days after your last dose of TUB-030.",114,"You would receive TUB-030 intravenously (through a vein) every 3 weeks. You will also visit the clinic every 3 weeks for checkups and tests, and answer questionnaires about your symptoms.","Not stated in the trial record.",[38]]