[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07186842":3,"trial-entities:NCT07186842":272,"trial-summary:NCT07186842":284},{"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":31,"primary_purpose":32,"phases":33,"enrollment_info":36,"interventions":39,"primary_outcomes":53,"secondary_outcomes":68,"sex":101,"minimum_age":102,"maximum_age":103,"healthy_volunteers":15,"eligibility_criteria":104,"std_ages":129,"locations":132,"central_contacts":259,"overall_officials":266,"references":270,"see_also_links":271},"NCT07186842","BNT329-01","A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9","First-in-human, Open-label, Multi-site, Phase I\u002FIIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT329 in Participants With Advanced Solid Tumors Known to Express CA19-9","RECRUITING","2030-05","2026-08","2026-08-27","2025-11-18","BioNTech SE","INDUSTRY",false,"The main goal of this study is to evaluate the safety of BNT329 and to identify the best dose of BNT329. This will be done by measuring the number of side effects that participants experience and how severe they are.\n\nThe second goal of this study is to evaluate how well BNT329 works. This will be done by measuring the number of participants who respond to the treatment. The length of time where the tumor does not grow or spread will also be measured.\n\nThe study will also evaluate how BNT329 moves into, through, and out of the body and how the treatment affects the body.","The study will consist of up to four parts (Parts A, B, C, and D).\n\nParts A and B will be a dose escalation to investigate the safety and tolerability of BNT329. Parts A and B will enroll participants with the following advanced solid tumors known to express carbohydrate antigen 19-9 (CA19-9): pancreatic ductal adenocarcinoma (PDAC) (the most common type of pancreatic cancer), bile duct cancer, a certain type of bladder cancer that started in the lining of the bladder or urinary tract (invasive urothelial carcinoma of the bladder and urinary tract), colorectal cancer, gastroesophageal junction cancer, gastric adenocarcinoma, endometrial cancer, or ovarian cancer. The cancer must not have responded well to previous treatments.\n\nThe study will start with recruitment into Part A. Part B (testing a more frequent dosing schedule) will only be opened if indicated by cumulative data from Part A of the study.\n\nPart C (testing pre-dosing with a CA19-9 targeting monoclonal antibody prior to BNT329 administration) will only be opened in case of unforeseen safety and\u002For weak efficacy signals are detected in Part A and (if opened) Part B. Details on Part C will be added in a future update, if it is necessary, to open this part.\n\nPart D will be a dose optimization and proof-of-concept study to further investigate the safety and tolerability of BNT329 and to investigate preliminary anti-tumor activity. Part D will enroll participants with second-line plus PDAC.\n\nParts A, B, and C will be non-randomized. In Part D, participants will be randomized (1:1) into one of two arms which will evaluate two dose levels (as selected from Parts A and B).\n\nThe study consists of a screening period, a treatment period, an end of treatment visit, two safety follow-up visits, and a survival follow-up period. The treatment period will last for a maximum of 2 years. Participants will remain in the survival follow-up until death, withdrawal of participant's consent, or termination of the study, whichever occurs first.",[19],"Advanced Solid Cancers",[21,22,23,24,25,26,27,28,29,30],"Anti-drug conjugate (ADC)","Bile duct cancer","CA19-9","Colorectal cancer","Endometrial cancer","Gastric adenocarcinoma","Gastroesophageal junction cancer","Invasive urothelial carcinoma of the bladder and urinary tract","Ovarian cancer","Pancreatic ductal adenocarcinoma","INTERVENTIONAL","TREATMENT",[34,35],"PHASE1","PHASE2",{"count":37,"type":38},245,"ESTIMATED",[40,49],{"type":41,"name":42,"description":43,"armGroupLabels":44},"DRUG","BNT329","Intravenous (IV) infusion",[45,46,47,48],"Dose Escalation - Part A","Dose Escalation - Part B","Dose Escalation: Part C","Dose Expansion - Part D",{"type":41,"name":50,"description":51,"armGroupLabels":52},"CA19-9-targeting monoclonal antibody","Monoclonal antibody",[47],[54,58,61,64],{"measure":55,"description":56,"timeFrame":57},"Parts A and B - Occurrence of dose-limiting toxicities within a participant","Per dose level.","First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.",{"measure":59,"description":56,"timeFrame":60},"Parts A, B, and D - Occurrence of treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs","From first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months).",{"measure":62,"description":56,"timeFrame":63},"Parts A, B, and D - Occurrence of dose interruptions, reductions, and discontinuation of BNT329 due to TEAEs","From the time of initiation of the first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months).",{"measure":65,"description":66,"timeFrame":67},"Part D - Objective response rate (ORR)","Per dose level. Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (based on the investigator's assessment) is observed as best overall response.","From first dose of BNT329 until end of study (up to approximately 36 months).",[69,72,75,77,79,82,85,88,91,94,98],{"measure":70,"description":71,"timeFrame":57},"Parts A, B, and D - Assessment of area under the curve derived from serum\u002Fplasma concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload","Per dose level (if data permit)",{"measure":73,"description":74,"timeFrame":57},"Parts A, B, and D - Assessment of maximum concentration derived from serum\u002Fplasma concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload","Per dose level (if data permit).",{"measure":76,"description":74,"timeFrame":57},"Parts A, B, and D - Assessment of time to reach maximum concentration derived from serum\u002Fplasma concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload",{"measure":78,"description":74,"timeFrame":57},"Parts A, B, and D - Assessment of terminal half-life derived from serum\u002Fplasma concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload",{"measure":80,"description":81,"timeFrame":67},"Parts A and B - ORR","Per dose level. Defined as the proportion of participants in whom a confirmed CR or PR (based on the investigator's assessment) is observed as best overall response.",{"measure":83,"description":84,"timeFrame":67},"Parts A, B, and D - Disease control rate","Per dose level. Defined as the proportion of participants in whom a CR or PR or stable disease (assessed at least 6 weeks \\[±2 days\\] after the first BNT329 dose) is observed as best overall response per investigator's assessment.",{"measure":86,"description":87,"timeFrame":67},"Parts A, B, and D - Duration of response","Per dose level. Defined as the time from first objective response (CR or PR) to first occurrence of objective tumor progression (PD) or death from any cause, whichever occurs first.",{"measure":89,"description":90,"timeFrame":67},"Parts A, B, and D - Progression free survival","Per dose level. Defined as the time from first dose of BNT329 to first objective tumor progression (PD per Response Evaluation Criteria in Solid Tumors version 1.1 \\[RECIST v1.1\\] based on the investigator's assessment), or death from any cause, whichever occurs first.",{"measure":92,"description":93,"timeFrame":67},"Part D - Overall survival","Per dose level. Defined as the time from first dose of BNT329 to death from any cause.",{"measure":95,"description":96,"timeFrame":97},"Parts A, B, and D: Anti-drug antibody (ADA) prevalence","Per dose level\u002Fcohort. Defined as the proportion of participants who are ADA positive at any timepoint (either baseline or post-baseline) (if data permit).","From first dose of BNT329 until up to 60 days after the last dose of BNT329 (up to 26 months).",{"measure":99,"description":100,"timeFrame":97},"Parts A, B, and D - ADA incidence","Per dose level\u002Fcohort. Defined as the proportion of participants having treatment-emergent ADA (if data permit).","ALL","18 Years",null,{"inclusion":105,"exclusion":115,"raw_text":128},[106,107,108,109,110,111,112,113,114],"Have an Eastern Cooperative Oncology Group performance score of 0 to 1","Have measurable disease per RECIST v1.1, except for ovarian cancer where participants will be evaluated according to Gynecologic Cancer InterGroup criteria.","Have a life expectancy of ≥3 months in the opinion of the investigator.","Have adequate organ, coagulation, and hematologic function as defined in the protocol.","Have a histologically confirmed advanced\u002Fmetastatic tumor type that is known to express CA19-9: PDAC, carcinoma of the bile ducts, invasive urothelial carcinoma of the bladder and urinary tract, colorectal adenocarcinoma, adenocarcinoma of the esophagogastric junction, gastric adenocarcinoma, endometrial carcinoma, and epithelial ovarian cancer (including adenocarcinoma of the fallopian tube and peritoneal epithelial cancer \\[except mesothelioma\\]).","Have no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator. Participants must have received all available standard therapies, including targeted therapies based on mutation status (per guidelines from the Food and Drug Administration, American Society of Clinical Oncology, European Society for Medical Oncology, or local guidelines used at the site), and failed at least first-line standard of care therapy prior to enrollment.","Have a histologically confirmed diagnosis of PDAC.","Must have been offered all available standard therapies including targeted therapies based on mutation status. Established second-line therapies available must not be withheld.","Have radiographic disease progression and no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator.",[116,117,118,119,120,121,122,123,124,125,126,127],"Are enrolled in another investigational study or are subject to exclusion periods from another investigational study.","Have had an inadequate washout period for prior anticancer treatment prior to the first dose of investigational medicinal product (IMP) as defined in the protocol.","Have received systemic steroids (\\>10 mg\u002Fday of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks prior to the first dose of IMP. The following are exceptions to this criterion:","Inhaled sprays, topical steroids, or local steroid injections (e.g., intra-articular injection).","Systemic steroids at physiological doses as replacement therapy (e.g., physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency).","Steroids as pre-medication for hypersensitivity reactions (e.g., computed tomography (CT) scan pre-medication).","Have received any live vaccine within 4 weeks prior to the first dose of IMP or intend to receive a live vaccine during the study.","Have brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anticonvulsants for at least 2 weeks prior to the first dose of IMP.","Have a history of (noninfectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.","Have active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal conditions that may cause bleeding or perforation in the opinion of the treating investigator.","Have an active infection that requires systemic therapy within 1 week prior to the first dose of IMP. Participants receiving prophylactic anti-infective therapy (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) may be eligible after discussion with the sponsor.","Have unresolved toxicities from previous anticancer therapy as defined in the protocol.","Key Inclusion Criteria\n\nAll participants and parts:\n\n* Have an Eastern Cooperative Oncology Group performance score of 0 to 1\n* Have measurable disease per RECIST v1.1, except for ovarian cancer where participants will be evaluated according to Gynecologic Cancer InterGroup criteria.\n* Have a life expectancy of ≥3 months in the opinion of the investigator.\n* Have adequate organ, coagulation, and hematologic function as defined in the protocol.\n\nParts A, B, and C:\n\n* Have a histologically confirmed advanced\u002Fmetastatic tumor type that is known to express CA19-9: PDAC, carcinoma of the bile ducts, invasive urothelial carcinoma of the bladder and urinary tract, colorectal adenocarcinoma, adenocarcinoma of the esophagogastric junction, gastric adenocarcinoma, endometrial carcinoma, and epithelial ovarian cancer (including adenocarcinoma of the fallopian tube and peritoneal epithelial cancer \\[except mesothelioma\\]).\n* Have no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator. Participants must have received all available standard therapies, including targeted therapies based on mutation status (per guidelines from the Food and Drug Administration, American Society of Clinical Oncology, European Society for Medical Oncology, or local guidelines used at the site), and failed at least first-line standard of care therapy prior to enrollment.\n\nPart D:\n\n* Have a histologically confirmed diagnosis of PDAC.\n* Must have been offered all available standard therapies including targeted therapies based on mutation status. Established second-line therapies available must not be withheld.\n* Have radiographic disease progression and no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator.\n\nKey Exclusion Criteria\n\nAll participants and parts:\n\n* Are enrolled in another investigational study or are subject to exclusion periods from another investigational study.\n* Have had an inadequate washout period for prior anticancer treatment prior to the first dose of investigational medicinal product (IMP) as defined in the protocol.\n* Have received systemic steroids (\\>10 mg\u002Fday of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks prior to the first dose of IMP. The following are exceptions to this criterion:\n\n  * Inhaled sprays, topical steroids, or local steroid injections (e.g., intra-articular injection).\n  * Systemic steroids at physiological doses as replacement therapy (e.g., physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency).\n  * Steroids as pre-medication for hypersensitivity reactions (e.g., computed tomography (CT) scan pre-medication).\n* Have received any live vaccine within 4 weeks prior to the first dose of IMP or intend to receive a live vaccine during the study.\n* Have brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anticonvulsants for at least 2 weeks prior to the first dose of IMP.\n* Have a history of (noninfectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Have active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal conditions that may cause bleeding or perforation in the opinion of the treating investigator.\n* Have an active infection that requires systemic therapy within 1 week prior to the first dose of IMP. Participants receiving prophylactic anti-infective therapy (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) may be eligible after discussion with the sponsor.\n* Have unresolved toxicities from previous anticancer therapy as defined in the protocol.\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply.",[130,131],"ADULT","OLDER_ADULT",[133,142,150,157,165,172,180,187,194,202,209,216,223,231,238,245,252],{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":138,"geoPoint":139},"SCRI at HCA Health One","Denver","Colorado","80218","United States",{"lat":140,"lon":141},39.73915,-104.9847,{"facility":143,"status":8,"city":144,"state":145,"zip":146,"country":138,"geoPoint":147},"Florida Cancer Specialists","Orlando","Florida","32827",{"lat":148,"lon":149},28.53834,-81.37924,{"facility":151,"status":8,"city":152,"state":152,"zip":153,"country":138,"geoPoint":154},"Memorial Sloan Kettering Cancer Center","New York","10065",{"lat":155,"lon":156},40.71427,-74.00597,{"facility":158,"status":8,"city":159,"zip":160,"country":161,"geoPoint":162},"Monash Health","Clayton","3168","Australia",{"lat":163,"lon":164},-37.91667,145.11667,{"facility":166,"status":8,"city":167,"zip":168,"country":161,"geoPoint":169},"Austin Health","Heidelberg","3084",{"lat":170,"lon":171},-37.75,145.06667,{"facility":173,"status":8,"city":174,"zip":175,"country":176,"geoPoint":177},"St. Josef-Hospital im Katholischen Klinikum Bochum","Bochum","44791","Germany",{"lat":178,"lon":179},51.48165,7.21648,{"facility":181,"status":8,"city":182,"zip":183,"country":176,"geoPoint":184},"Klinikum der Universität München","München","81377",{"lat":185,"lon":186},51.60698,13.31243,{"facility":188,"status":8,"city":189,"zip":190,"country":176,"geoPoint":191},"Universitaetsklinikum Ulm","Ulm","D-89081",{"lat":192,"lon":193},48.39841,9.99155,{"facility":195,"status":8,"city":196,"zip":197,"country":198,"geoPoint":199},"Hospital Universitari Vall d'Hebron","Barcelona","08035","Spain",{"lat":200,"lon":201},41.38879,2.15899,{"facility":203,"status":8,"city":204,"zip":205,"country":198,"geoPoint":206},"Hospital San Pedro","Logroño","26006",{"lat":207,"lon":208},42.46615,-2.45115,{"facility":210,"status":8,"city":211,"zip":212,"country":198,"geoPoint":213},"Hospital Universitario HM Sanchinarro - START Madrid CIOCC","Madrid","28050",{"lat":214,"lon":215},40.4165,-3.70256,{"facility":217,"status":8,"city":218,"zip":219,"country":198,"geoPoint":220},"Hospital Universitario Quironsalud Madrid - NEXT Oncology","Pozuelo de Alarcón","28223",{"lat":221,"lon":222},40.43293,-3.81338,{"facility":224,"status":8,"city":225,"zip":226,"country":227,"geoPoint":228},"St James´s University Hospital","Leeds","LS9 7TF","United Kingdom",{"lat":229,"lon":230},53.79648,-1.54785,{"facility":232,"status":8,"city":233,"zip":234,"country":227,"geoPoint":235},"Royal Free Hospital","London","NW3 2QG",{"lat":236,"lon":237},51.50853,-0.12574,{"facility":239,"status":8,"city":240,"zip":241,"country":227,"geoPoint":242},"The Christie NHS Foundation Trust","Manchester","M20 4BX",{"lat":243,"lon":244},53.48095,-2.23743,{"facility":246,"status":8,"city":247,"zip":248,"country":227,"geoPoint":249},"Northern Centre for Cancer Research","Newcastle upon Tyne","NE7 7DN",{"lat":250,"lon":251},54.97328,-1.61396,{"facility":253,"status":8,"city":254,"zip":255,"country":227,"geoPoint":256},"The Royal Marsden Hospital","Sutton","SM2 5PT",{"lat":257,"lon":258},51.35,-0.2,[260],{"name":261,"role":262,"phone":263,"phoneExt":264,"email":265},"BioNTech clinical trials patient information","CONTACT","+49 6131 9084","0","patients@biontech.de",[267],{"name":268,"affiliation":13,"role":269},"BioNTech Response Person","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":273,"biomarkers":283},[274,275,276,277,278,279,280,281,282],"Cholangiocarcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Ovarian Carcinoma","Pancreatic Ductal Adenocarcinoma","Solid Neoplasm","Urothelial Carcinoma",[23],{"nct_id":4,"found":285,"summary":286,"prompt_version":296},true,{"design":287,"status":288,"heading":289,"summary":290,"follow_up":291,"word_count":292,"commitments":293,"compensation":294,"drugs_mentioned":295},"This is an interventional study with a planned enrollment of 245 participants. It will involve different parts to investigate the safety and tolerability of BNT329.","completed","BNT329 for Advanced Solid Tumors with CA19-9","This clinical trial is testing a drug called BNT329 for people with advanced solid tumors that have a specific marker called CA19-9. The main goals are to see if BNT329 is safe, find the best dose, and understand its side effects. Researchers will also look at how well BNT329 works by measuring if tumors shrink or stop growing. The study is open to adults aged 18 and older who have certain advanced solid tumors, such as pancreatic, bile duct, bladder, colorectal, or ovarian cancer, that haven't responded well to previous treatments. You must also have a good general health status and a life expectancy of at least 3 months. BNT329 is a monoclonal antibody, which is a type of protein designed to target specific cells.","Participants will be followed for treatment-emergent adverse events (side effects) from the first dose of BNT329 until 60 days after the last dose, which could be up to 26 months.",125,"Not specified in the trial record.","Not stated in the trial record.",[42],"v2"]