[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BioNTech SE\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":627},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,46,79,114,138,171,201,224,250,279,304,330,360,398,422,453,475,499,520,543,577,604],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100053770","phase-1-a-clinical-trial-to-look-at-the-safety-and-immune-responses-of-the-rna-based-vaccine-bnt168-in-adults-living-with-or-without-hiv-100053770",false,"NCT07698600","A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV","A Randomized, Placebo-controlled, Phase I\u002FII Clinical Trial to Evaluate the Safety, Immunogenicity, and Impact on Virological Control of the Investigational RNA-based Vaccine BNT168 in Adults Living With or Without HIV","Key Inclusion Criteria:\n\n* Are 18 to 50 years of age inclusive at the time of giving informed consent.\n* For PLWOH: Individuals who are HIV-1 and HIV-2 negative at Visit 0. For PLWH: Individuals who are HIV-1 positive and HIV-2 negative at Visit 0.\n* Have not received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.\n* Are overall healthy as defined in the protocol.\n* Individuals who have screening hematology and\u002For blood chemistry laboratory values as defined in the protocol.\n* For PLWOH, starting at Visit 0 and continuously until the last planned visit in this study, individuals who:\n\n  * Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.\n  * Agree to discuss HIV disease risks.\n  * Agree to HIV infection risk reduction counseling.\n* For PLWH, individuals who:\n\n  * Have been on stable continuous cART for at least 12 months (defined as no interruptions longer than 14 continuous days) and with no changes in the components of the cART for at least 12 weeks prior to Visit 1.\n  * Are not on a non-nucleoside reverse transcriptase inhibitor at screening.\n  * Have never received lenacapavir and have not received other long-acting antiretroviral therapies in the last 2 years (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).\n  * Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners.\n  * Have a CD4+ T cell count of ≥500 cells\u002FµL at Visit 0.\n  * Per medical history, any available prior CD4+ T cell count must be ≥350 cells\u002FµL.\n  * Have plasma HIV-1 RNA levels of \\\u003C50 cps\u002FmL for ≥6 months prior to study entry per investigator review of records and\u002For participant history (single measurements of \\\u003C200 cps\u002FmL are allowed if preceded and followed by values of \\\u003C50 cps\u002FmL).\n  * Are willing to stop cART and undergo ATI at the timepoint defined in the protocol.\n  * Are willing to re-initiate cART upon meeting cART restart criteria.\n  * Site investigator anticipates that a fully active alternative cART regimen could be constructed and would be available in the event of virologic failure on the participant's current cART regimen.\n* Agree not to donate blood from the time of first IMP administration until 90 days after the last IMP administration for PLWOH and until the End of Study Visit for PLWH.\n\nKey Exclusion Criteria:\n\n* Have had major surgery (e.g., major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before Visit 0, or will not have fully recovered from surgery, or have major surgery planned during the time the participants are expected to participate in the study.\n* Have an abnormal electrocardiogram at Visit 0 as specified in the protocol.\n* Have any existing condition which may affect IMP injection and\u002For assessment of local reactions, e.g., tattoos, severe scars, etc.\n* Have any bleeding diathesis or condition associated with prolonged bleeding that, in the opinion of the investigator, could compromise their wellbeing if they participate in the study.\n* Have any current febrile illness (body temperature \\>38.0°C\u002F\\>100.4°F) or other acute illness within 48 hours prior to IMP administration\n* Have any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias, or any clinically significant cardiac disease per the investigator's judgment.\n* Have Grade ≥2 hypertension per Food and Drug Administration toxicity grading scale at screening.\n* Have a known or suspected impairment\u002Falteration of immune function, autoimmune disease, or immunodeficiency (except HIV for PLWH), including receipt of any immunostimulant, immunomodulator, immunosuppressive medication, immunoglobulin, or blood\u002Fplasma product within 60 days prior to Visit 1 or planned administration during the study. Use of inhaled, intranasal, topical, or locally injected corticosteroids (e.g., intraarticular or intrabursal administration) is acceptable.\n* Have a history of malignancy within 5 years before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered in the investigator's judgment to have minimal risk of recurrence. Any malignancy that is an AIDS-defining illness per protocol is exclusionary regardless of perceived risk of recurrence.\n* Have received any live vaccines within 28 days prior to Visit 0 or any other vaccines within 14 days prior to Visit 0 or who are planning to receive any vaccine within 28 days of each IMP dose. When possible, standard of care vaccinations should be planned with the study interventions in mind.\n* For PLWH: Have a history of opportunistic infections and\u002For AIDS-defining illnesses according to the US Centers for Disease Control and Prevention 2014 and the National Institutes of Health 2024.\n* For PLWOH: Have current untreated or incompletely treated active tuberculosis infection (by history or concerning symptoms). For PLWH: Have current untreated or incompletely treated active tuberculosis infection (by history or concerning symptoms or sputum molecular testing) or current latent tuberculosis infection (by blood interferon-gamma release assay \\[IGRA\\]). Not excluded: Participants who have a positive IGRA but were fully treated for latent or active tuberculosis infection, per history, review of available records, and per investigator discretion.\n* For PLWH: Have untreated or incompletely treated syphilis or genital, oropharyngeal or rectal gonorrhea or chlamydia infection.\n* For PLWH: Have a history of multi-class drug resistant HIV-1 infection defined as resistance to three or more classes of HIV drugs.\n* Have an estimated glomerular filtration rate of \\\u003C45 mL\u002Fmin\u002F1.73 m2 using the 2021 chronic kidney disease epidemiology creatinine equation.\n* History of any serious adverse reactions (including anaphylaxis, respiratory distress, angioedema, or urticaria) to vaccines or to vaccine components such as lipids.\n* Have a history of progressive or severe neurologic disorder, seizure disorder, or Guillain-Barré syndrome.\n* Have a history of diabetes mellitus type 1 or type 2, a screening hemoglobin A1c ≥6.5%, or are taking any medication for treatment of diabetes. (Not excluded: A history of isolated gestational diabetes.)\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",true,"ALL","18 Years","50 Years",{"count":21,"type":22},126,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and how it affects the amount of virus in the body.",[28],"HIV -1 Infection",[30,31,32,33],"HIV (human immunodeficiency virus)","combination antiretroviral therapy (cART)","Acquired immunodeficiency syndrome (AIDS)","Ribonucleic acid (RNA)-based vaccine","NOT_YET_RECRUITING","2026-07-07",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":22},"2026-07",{"date":42,"type":22},"2028-01",{"name":44,"class":45},"BioNTech SE","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100599064","phase-1-a-clinical-study-to-test-if-an-investigational-treatment-called-bnt314-when-used-in-combination-with-another-investigational-treatment-pumitamig-bnt327-and-chemotherapy-is-beneficial-and-safe-for-patients-with-advanced-colorectal-cancer-100599064","NCT07079631","A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer","A Phase I\u002FII, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With Pumitamig and Chemotherapy in Participants With Metastatic Colorectal Cancer","Key Inclusion Criteria:\n\n* Have unresectable histologically confirmed adenocarcinoma of the colon or rectum.\n* Have confirmed non-microsatellite instability-high (non-MSI-H)\u002FpMMR mCRC per Food and Drug Administration (FDA)\u002FEuropean Commission (EC) approved test or based on local testing.\n* Have measurable disease defined by RECIST v1.1.\n* Must provide a tumor tissue sample (formalin-fixed, paraffin-embedded or tissue slides) collected before C1D1 for enrollment. A newly obtained tumor sample is preferred. If it is not feasible to obtain a recent tumor sample, participants can provide archival tumor tissue (less than 2 years prior treatment).\n* Have Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Have a life expectancy of ≥12 weeks.\n* Have an adequate organ and bone marrow function within ≤7 days of Day 1 as defined in the protocol.\n* Have had an adequate previous treatment washout period before randomization\u002Fenrollment as defined in the protocol.\n\nInclusion criteria applicable to only protocol-specific cohorts:\n\n* Have histologically confirmed metastatic colorectal cancer and radiographically documented disease progression after ≥2 prior lines of systemic therapy for metastatic disease as defined in the protocol.\n* Have progressed following first-line chemotherapy as specified in the protocol.\n* Have not received prior systemic therapy for MSS\u002FpMMR mCRC. Participants who received chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease in the neoadjuvant or adjuvant setting are eligible for the study if therapy was completed at least 6 months prior to initiation of study treatment.\n\nOther cohort-specific inclusion criteria apply.\n\nKey Exclusion Criteria:\n\n* Confirmed MSI-H\u002Fdeficient mismatch repair mCRC (per FDA\u002FCE approved test or based on local testing).\n* Prior treatment with epithelial cell-adhesion molecule or 4-1BB targeted or immunotherapy.\n* Prior treatment with immune checkpoint inhibitors or programmed death-ligand 1 (PD\\[L\\]-1)\u002Fvascular endothelial growth factor bispecific antibody.\n* Is a candidate to locoregional treatment (including surgical resection, stereotactic radiation therapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as \"radical\" intent), per investigator's assessment.\n* Have uncontrolled or significant cardiovascular disease as specified in the protocol.\n* Have left ventricular ejection fraction \\\u003C50% by echocardiogram or multigated acquisition within 28 days before randomization\u002Fenrollment.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization\u002Fenrollment.\n* Have clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. Participants with untreated, asymptomatic brain metastases for whom local therapy is not indicated per SoC may be eligible if neurologically stable and (if deemed necessary by the investigator). Except for brain metastases history, any participants at imminent risk for spinal cord compression or leptomeningeal disease are not eligible.\n* Have unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline toxicities that have resolved with sequelae (e.g., tracheostomy, chronic use of feeding tube, replacement hormones) are allowed, if not associated with increased risk of complications per investigator's assessment.\n* Participants in Part B or C who fulfill one of the conditions:\n\n  * Prior treatment with anticancer therapies (as defined in the protocol) with unusual toxicity, or\n  * Known dihydropyrimidine dehydrogenase (DPD) deficiency, testing performed according to the local guidelines. If not tested, lack of DPD activity must be tested for the participants who have not received anticancer therapies (as defined in the protocol) in the prior lines of treatment; testing should be performed according to the local guidelines.\n* Have a history of another primary malignancy within 2 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated (adjuvant hormone therapy for malignancies at low risk of relapse is allowed) or have a known additional malignancy that is progressing or requires treatment.\n* Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.\n* Have 24-h urine protein excretion ≥1 g. If qualitative urine protein is ≤1+, a 24-h urine protein quantitative test is not required.\n* Have active autoimmune disease or a history of autoimmune disease (myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, vasculitis, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis) with a risk of exacerbation following PD-L1 inhibition or have an immune deficiency (allogeneic hematopoietic stem cell transplantation or organ transplantation). Participants with protocol-specified conditions may be eligible.\n* Have serious non-healing wounds, ulcers, or bone fractures. This includes history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess or esophageal and gastric varices, acute gastrointestinal bleeding for which an interval of 6 months must pass before enrollment into this study. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation\u002Ffistula and\u002For the underlying process causing the fistula\u002Fperforation.\n* Have evidence of major coagulation disorders or other significant risks of hemorrhage as specified in the protocol.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":54,"type":22},482,[25,56],"PHASE2","This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's own defense to fight cancer in combination with another new treatment (pumitamig, which is a cancer immunotherapy drug also known as BNT327 and PM8002) and chemotherapy in participants with metastatic colorectal cancer (mCRC).",[59],"Metastatic Colorectal Cancer",[61,62,63,64,65,66,67,68],"Microsatellite stable or mismatch repair proficient (MSS\u002FpMMR) tumors","Immune checkpoint inhibitor","Programmed death-ligand 1 (PD-L1)","Vascular endothelial growth factor-A (VEGF-A)","Bispecific antibody","Immunotherapy","Combination chemotherapy","Dose optimization","RECRUITING","2026-06-30",{"date":72,"type":38},"2026-07-01",{"date":74,"type":38},"2025-07-18",{"date":76,"type":22},"2032-12",{"name":44,"class":45},14,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100570831","phase-3-safety-and-efficacy-of-bnt327-an-investigational-therapy-in-combination-with-chemotherapy-for-patients-with-untreated-small-cell-lung-cancer-100570831","NCT06712355","Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer","A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide\u002FCarboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide\u002FCarboplatin) in Participants With First-line Extensive-stage Small-cell Lung Cancer","Inclusion Criteria:\n\n* Have histologically or cytologically confirmed ES-SCLC (using the AJCC \\[American Joint Committee on Cancer\\] tumor node metastasis staging system combined with Veterans Administration Lung Study Group \\[VALG\\]'s two stage classification scheme). For AJCC tumor node metastasis staging system: AJCC 8th edition stage IV (T any, N any, M1a\u002Fb\u002Fc), or T3\\~4 for multiple lung nodules or tumor\u002Fnodule volume that cannot be encompassed in a tolerable radiotherapy plan.\n* Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic and organ function as defined in the protocol.\n\nExclusion Criteria:\n\n* Have histologically or cytologically confirmed SCLC with combined histologies.\n* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:\n\n  * Within 2 weeks: small molecule agents with half-life of \\\u003C7 days; radiation outside the thoracic cavity including whole brain radiation. Of note, other local radiation for brain lesions (not whole brain) is allowed; local radiation for bone lesions is allowed. Palliative bone radiation or brain stereotactic radiosurgery would not require a washout period, but participants should recover from radiotherapy-related toxicity.\n  * Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.\n  * Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed death (ligand)-1 (PD\\[L\\]-1)\u002FVEGF bispecific antibody.\n  * Have received systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.\n* Have the following central nervous system metastases:\n\n  * Participants with untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).\n  * Participants with treated central nervous system (CNS) metastases who are not neurologically stable or on steroids (at a dosage greater than 10 mg\u002FDay of prednisone or an equivalent dose of other corticosteroid) within 7 days before initiating study treatment of this study.\n  * Participants with known leptomeningeal metastases.\n* Have uncontrolled hypertension or poorly controlled diabetes prior to study treatment.\n* Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before study entry. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation\u002Ffistula and\u002For the underlying process causing the fistula\u002Fperforation.\n* Have a significant risk of hemorrhage (per investigator clinical judgment) as defined in the protocol.\n* Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":87,"type":22},621,[89],"PHASE3","This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide\u002Fcarboplatin) compared to atezolizumab combined with chemotherapy (etoposide\u002Fcarboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).",[92],"Extensive-stage Small-cell Lung Cancer",[94,95,96,97,65,63,98,66,99,100,101,102,103,104,105,106],"First-line ES-SCLC","SCLC","Immunotherapy in combination with chemotherapy","Untreated","Vascular endothelial growth factor (VEGF) A","Combination with other investigational agents","Pumitamig","BNT327","Check point inhibitor","Lung cancer","Etoposide","Carboplatin","Cisplatin",{"date":72,"type":38},{"date":109,"type":38},"2025-02-03",{"date":111,"type":22},"2029-03",{"name":44,"class":45},211,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},"100570828","phase-2-safety-efficacy-and-pharmacokinetics-of-bnt327-in-combination-with-chemotherapy-and-other-investigational-agents-for-lung-cancer-100570828","NCT06712316","Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer","A Phase II\u002FIII, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer","Key Inclusion Criteria:\n\n* Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer\u002FAmerican Joint Committee on Cancer staging system, 9th edition.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Adequate organ function.\n\nKey Exclusion Criteria:\n\n* Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic or neuroendocrine component.\n* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:\n\n  * Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neo-adjuvant\u002Fadjuvant or locally advanced\u002Fmetastatic setting.\n  * Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1\u002FVEGF bispecific antibody\n  * Have received systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\\\u003C=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.\n* Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.\n* Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation\u002Ffistula and\u002For the underlying process causing fistula\u002Fperforation.\n* Participants with significant risk of hemorrhage (per investigator clinical judgment).\n* Have superior vena cava syndrome or symptoms of spinal cord compression.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":122,"type":22},1260,[56,89],"This is a Phase 2\u002F3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).\n\nThis study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.",[126],"Non-small Cell Lung Cancer",[128,129,99,65,63,98,66,130],"First-line treatment","Combination with chemotherapy","Programmed Death-1 monoclonal antibodies",{"date":72,"type":38},{"date":133,"type":38},"2025-01-07",{"date":135,"type":22},"2030-03",{"name":44,"class":45},261,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":146,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100542261","phase-3-a-clinical-study-of-the-anti-cancer-effects-of-an-investigational-therapy-or-chemotherapy-in-patients-with-recurring-uterine-cancer-100542261","NCT06340568","A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer","A Phase III, Randomized, Multi-site, Open-label Trial of BNT323\u002FDB-1303 Versus Investigator's Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer","Fern-EC-01","Key Inclusion Criteria:\n\n* Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of voluntarily giving informed consent).\n* Have histologically confirmed endometrial cancer that:\n\n  * Is recurrent,\n  * Has a HER2 IHC score of 1+, 2+ (Cohort 1), or 3+ (Cohort 2) as determined by central laboratory testing for HER2 expression, and\n  * Is not defined as a true sarcoma (i.e., leiomyosarcoma or endometrial stromal sarcoma). Note: Uterine carcinosarcoma is allowed.\n* Have measurable disease defined by RECIST v1.1.\n* Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Have recurrent endometrial cancer and meet any of the following:\n\n  * developed recurrence \\\u003C12 months from completing platinum-based chemotherapy given as adjuvant therapy for Stage I to III disease, or\n  * developed recurrence after platinum-based chemotherapy in the recurrent\u002Fmetastatic setting.\n* Have received prior ICI treatment (i.e., anti-programmed death 1\u002Fanti-programmed death-ligand 1)\n* Have a life expectancy of ≥12 weeks at screening.\n\nKey Exclusion Criteria:\n\n* Are ineligible for all options in the investigator's choice of chemotherapy arm, per local prescribing information and institutional guidelines (applicable to Cohort 1 only).\n* Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior the first dose of study treatment.\n* Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, or peritoneal shunt within 2 weeks prior to the first dose of study treatment.\n* Have a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Participants with prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses of less than 10 mg\u002Fday of prednisone or equivalent, and topical corticosteroids. Participants receiving corticosteroids may continue if the dose is stable upon giving main informed consent.\n* Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to the first dose of study treatment, severe asthma, chronic obstructive pulmonary disorder with moderate acute exacerbations, restrictive lung disease, pulmonary fibrosis, radiation pneumonitis, significant pleural effusion etc.), or any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and\u002For prior pneumonectomy (complete).\n* Have uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the first dose of study treatment.\n* Have unresolved toxicities from previous anti-cancer therapy, defined as toxicities (other than alopecia, fatigue, or endocrinopathies that are well controlled) not yet resolved to Grade ≤1 or baseline.\n* Are pregnant or breastfeeding or are planning pregnancy during the study or within 7 months after the last dose of study treatment.\n* Have a history of allergies, hypersensitivities, or intolerance to study treatments (investigational medicinal products and auxiliary medicinal product) including any excipients thereof or to other monoclonal antibodies. Participants who have successfully undergone a desensitization process and are able to tolerate the drug are eligible.\n* Had prior treatment with topoisomerase I inhibitors, including ADCs.\n* Have left ventricular ejection fraction \\\u003C55% by either echocardiography or multiple-gated acquisition within 28 days prior to the first dose of study treatment. This includes participants with tissue doppler E\u002Fe' ratio \\>15.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.","FEMALE",{"count":148,"type":22},480,[89],"The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample.\n\nIn Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or chemotherapy (doxorubicin or paclitaxel \\[or docetaxel, if participants cannot take paclitaxel\\]) works by determining the progression-free survival (PFS) of participants who have been previously treated with immune checkpoint inhibitors (ICIs).\n\nIn Cohort 2, the main goal is to assess how well BNT323 works by determining the objective response rate (ORR), that is, the percentage of participants whose tumor shrinks (partial response) or disappears (complete response) after treatment.\n\nThe safety of BNT323 will also be assessed by following the occurrence of unfavorable\u002Fadverse effects that are seen after treatment. Other measures include the pharmacokinetics of BNT323 (or how BNT323 moves through and out of the body), the body's immune response, and the impact on quality of life.",[152],"Endometrial Cancer",[154,155,156,157,62,158,159,160,161,162],"Human epidermal growth factor receptor 2 (HER2)","HER2-expressing tumors","Recurrent endometrial cancer","IHC scores 1+, 2+, and 3+","Platinum-based therapy","HER2 protein expression","HER2-expressing endometrial cancer","ErbB-2 receptor","Antibody drug conjugate (ADC)","2026-06-29",{"date":70,"type":38},{"date":166,"type":38},"2025-06-10",{"date":168,"type":22},"2029-11",{"name":44,"class":45},163,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":178,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100621082","phase-3-a-phase-iii-trial-of-bnt324-versus-docetaxel-in-metastatic-castration-resistant-prostate-cancer-100621082","NCT07365995","A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer","A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone\u002FPrednisolone in Metastatic Castration-resistant Prostate Cancer","Key Inclusion Criteria:\n\n* Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).\n* Must have documented progressive prostate cancer based on at least one of the following criteria:\n\n  * Serum\u002Fplasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng\u002FmL.\n  * Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.\n  * Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria.\n* Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy.\n* Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC.\n* Must have had prior orchiectomy and\u002For have ongoing androgen-deprivation therapy and a castrate-level of serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study.\n* Must have an Eastern Cooperative Oncology Group performance score of 0 or 1.\n\nKey Exclusion Criteria:\n\n* Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs.\n* Have uncontrolled or significant cardiovascular disease, as defined in the protocol.\n* Have a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids or have current ILD\u002Fpneumonitis.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.","MALE",{"count":180,"type":22},736,[89],"This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC.\n\nThe main goals of this study are:\n\n* To find out if BNT324 helps participants live longer without their cancer getting worse (radiographic progression-free survival \\[rPFS\\]).\n* To find out if BNT324 helps participants live longer overall (overall survival \\[OS\\]).",[184],"Metastatic Castration-resistant Prostate Cancer",[66,186,187,188,189,190,191],"Antibody-drug conjugate (ADC)","Standard of care (SoC)","Chemotherapy","Steroids","BNT324 (DB-1311)","mCRPC","2026-06-25",{"date":194,"type":38},"2026-06-26",{"date":196,"type":38},"2026-04-22",{"date":198,"type":22},"2031-02",{"name":44,"class":45},9,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},"100606299","phase-3-rosetta-breast-01-the-effects-and-safety-of-pumitamig-in-patients-with-triple-negative-breast-cancer-100606299","NCT07173751","ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer","A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease","Inclusion Criteria:\n\n* Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.\n* Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER and\u002For progesterone receptor \\[PgR\\]) 1% to 10%, HER2 immunohistochemistry \\[IHC\\] 0, 1+, or 2+ with fluorescence in situ hybridization \\[FISH\\] negative for HER2 gene amplification) documented prior to trial screening as part of standard of care.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.\n* Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to participate in the trial).\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Have received any of the following therapies or drugs prior to the initiation of trial:\n\n  * Have received prior systemic anticancer therapy for advanced disease.\n  * Have received prior treatment with a PD(L)-1\u002Fvascular endothelial growth factor (VEGF) bispecific antibody.\n  * Have received systemic corticosteroids (at a dosage greater than 10 milligrams \\[mg\\]\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of trial treatment. Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\\\u003C= 7 days) of corticosteroids for prophylaxis (for example, prevention of contrast agent allergy) or treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by exposure to allergens).\n  * Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment.\n  * Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.\n* Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.\n* Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed.\n* Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.",{"count":209,"type":22},558,[89],"This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.",[213],"Breast Neoplasms",[215,65,63,66,96,99],"Metastatic TNBC","2026-06-24",{"date":192,"type":38},{"date":219,"type":38},"2025-10-30",{"date":221,"type":22},"2030-09",{"name":44,"class":45},143,{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},"100584684","phase-1-a-clinical-study-to-investigate-the-efficacy-and-safety-of-an-investigational-combination-therapy-with-bnt324-and-bnt327-in-patients-with-advanced-lung-cancer-100584684","NCT06892548","A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer","A Phase Ib\u002FII, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced Lung Cancer","Inclusion Criteria:\n\n* Aged ≥18 years at the time of giving informed consent.\n* Histological or cytological confirmed unresectable advanced\u002Fmetastatic lung cancer. Histological classification may be based on tumor samples prior to metastatic disease. Participants with mixed histology must be classified based on the main component. Participants with NSCLC are eligible with any or no PD-L1 expression. Participants with AGA-positive disease must have received targeted therapy prior to enrollment in this study.\n\n  * Part 1: Participants with NSCLC and SCLC\n  * Part 2 Cohort 1: Participants with NSCLC (subpopulation 1) AGA negative, 1L\n  * Part 2 Cohort 2: Participants with SCLC, 2L+\n  * Part 2 Cohort 3: Participants with NSCLC (subpopulation 1) AGA negative, 2L+\n  * Part 2 Cohort 4: Participants with NSCLC (subpopulation 2) AGA negative, 1L\n  * Part 2 Cohort 5: Participants with NSCLC (subpopulation 2) AGA negative, 2L+\n  * Part 2 Cohort 6: Participants with NSCLC AGA positive\n  * Part 2 Cohort 7: Participants with SCLC, 1L\n* Have measurable disease defined by RECIST version 1.1.\n* Have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have a life expectancy of ≥12 weeks.\n\nExclusion Criteria:\n\n* Prior treatment with B7-H3 targeted therapy.\n* Prior treatment with ADC with topoisomerase inhibitor (e.g., datopotamab deruxtecan, trastuzumab deruxtecan). Note: This exclusion applies to participants in the first-line\u002Ftreatment-naïve cohorts in the advanced\u002Fmetastatic setting. Prior treatment with ADC with topoisomerase inhibitor payload is only allowed for participants in the second-line plus cohorts in the advanced\u002Fmetastatic setting.\n* Is a candidate to locoregional treatment (including surgical resection, stereotactic radiotherapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as \"radical\" intent), per investigator's assessment.\n* Has a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent\u002Fpersistent Grade 3 to 4 neutropenia.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply to all or some participants depending on the cohort.",{"count":232,"type":22},594,[25,56],"This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced\u002Fmetastatic or relapsed\u002Fprogressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).",[236],"Advanced Lung Cancer",[238,239,63,240,65,190,101,129,99,66,241],"Small cell lung cancer (SCLC)","Non-small cell lung cancer (NSCLC)","Vascular endothelial growth factor (VEGF)","Treatment-naïve","2026-06-23",{"date":216,"type":38},{"date":245,"type":38},"2025-05-02",{"date":247,"type":22},"2032-05",{"name":44,"class":45},86,{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":265,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},"100579664","phase-1-a-clinical-study-to-find-the-optimal-dose-of-an-investigational-treatment-called-bnt323-when-used-in-combination-with-another-investigational-treatment-bnt327-and-to-test-if-that-combination-treatment-is-safe-and-beneficial-for-patients-with-advanced-breast-cancer-100579664","NCT06827236","A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer","A Phase I\u002FII, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer","Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified):\n\n* Have pathologically documented BC that:\n\n  * Is locally advanced, unresectable or metastatic.\n  * Has a confirmed HER2 status as determined by the local laboratory as standard of care testing prior to study screening (Part 1, Part 2 Cohorts 2 and 4) or the central laboratory (Part 2, Cohorts 1 and 3) from the most recently collected pre-randomization tumor sample.\n  * Has a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Clinical Oncology\u002FCollege of American Pathologists guidelines.\n* Have measurable disease defined by RECIST v1.1.\n* Has left ventricular ejection fraction ≥55% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization\u002Fenrollment.\n\nKey Exclusion Criteria:\n\n* Have history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.\n* Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization\u002Fenrollment.\n* Have a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Had prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads such as trastuzumab deruxtecan.\n* Have received any of the following therapies or drugs prior to the initiation of the study:\n\n  * Participants who have received prior treatment with BNT323.\n  * Participants who received prior treatment with a programmed death-ligand 1 (PD-L1) \u002F vascular endothelial growth factor (VEGF) bispecific antibody. Note: Prior treatment with programmed death 1 (PD-1)\u002FVEGF bispecific antibodies, PD-1\u002FPD-L1 inhibitors or anti-VEGF therapies are permitted.\n  * Have received other systemic immunostimulatory agents or immunosuppressive therapies (such as interferon-α, interleukin-2, or methotrexate) within 4 weeks prior to the initiation of study treatment or are within five half-lives of the treatment drug (whichever is longer). Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).\n  * Have received systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 3 weeks prior to the initiation of study treatment.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":258,"type":22},380,[25,56],"This is a Phase I\u002FII, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \\[IHC\\] 1+ or IHC 2+\u002Fin situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).",[262,263,264],"Locally Advanced Breast Cancer","Unresectable Breast Carcinoma","Metastatic Breast Cancer",[266,154,267,162,268,269,130,270],"Breast Cancer (BC)","IHC scores 0, 1+, 2+, and 3+","Programmed Death-1 (PD-1)","Programmed Death Ligand-1 (PD-L1)","Anti vascular endothelial growth factor-A (anti-VEGF-A)","2026-06-22",{"date":242,"type":38},{"date":274,"type":38},"2025-04-23",{"date":276,"type":22},"2029-08",{"name":44,"class":45},56,{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":303},"100623110","phase-1-a-clinical-trial-investigating-the-safety-and-biological-activity-of-the-antibody-bnt351-in-adults-living-without-and-with-hiv-100623110","NCT07392372","A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV","A Phase I First-in-human Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of the Broadly Neutralizing Antibody BNT351 in Adults Living Without and With HIV","Key Inclusion Criteria\n\nPart A:\n\n* Are HIV-1 and HIV-2 negative at Visit 0.\n* Starting at Visit 0 and continuously until the last planned visit in this study are individuals who:\n\n  1. Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.\n  2. Agree to discuss HIV disease risks;\n  3. Agree to HIV acquisition risk reduction counseling;\n\nPart B:\n\n* Are HIV-1 positive and HIV-2 negative at Visit 0.\n* Individuals who at Visit 0:\n\n  1. Are cART-naïve individuals who were diagnosed with HIV-1 infection ≤12 months prior to screening, OR are individuals who have discontinued cART and who were diagnosed with HIV-1 infection ≤12 months prior to screening or ≤18 months if this is found to be acceptable after discussion on a case-by-case basis with the sponsor's medical monitor.\n  2. If cART-experienced, have discontinued cART for at least 4 weeks before screening (if the individual was taking long-acting antiretroviral therapy \\[ART\\]), see the following bullet). For individuals who have discontinued cART: Are able to comply with study procedures and assessments in the investigator's judgment.\n  3. Have never received lenacapavir or ibalizumab or fostemsavir, and have not received other long-acting ARTs in the last 6 months (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).\n  4. Have a CD4+ T cell count of ≥500 cells\u002FµL and plasma HIV-1 RNA levels between 5,000-100,000 copies\u002FmL at screening.\n  5. Are willing to initiate cART at a protocol-defined timepoint (56 days post-dose, or earlier if meeting early cART start criteria or at investigator's discretion).\n  6. Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners.\n\nKey Exclusion Criteria:\n\nParts A and B:\n\n* Have received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.\n* Have a known or suspected impairment\u002Falteration of immune function or immunodeficiency (except for HIV infection, applicable to Part B only), including receipt of any immunostimulant, immunomodulator, immunosuppressive medication, immunoglobulin, blood product, or oral or parenteral steroid within 60 days prior to Day 1 or planned administration during the study. The following exception applies: Use of inhaled, intranasal, topical, or locally injected corticosteroids (e.g., intraarticular or intrabursal administration) is allowed.\n* Have a history of generalized urticaria or angioedema, or of allergy, anaphylaxis, hypersensitivity or intolerance to a human or humanized antibody or to BNT351 excipients.\n\nPart B only:\n\n* Are receiving ongoing therapy for Mycobacterium tuberculosis infection.\n* Have a history of opportunistic infections\u002FAIDS-defining illnesses as defined in the protocol.\n* Have a history of multi-class drug resistant HIV-1 infection defined as resistance to three or more classes of HIV drugs.\n* Have a history of malignancy within 5 years before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered in the investigator's judgment to have minimal risk of recurrence. Any malignancy that is an AIDS-defining illness (as defined in the protocol) is exclusionary regardless of the perceived risk of recurrence.\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply.","65 Years",{"count":288,"type":22},67,[25],"This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV). This study will also test the anti-viral activity of BNT351 in people living with HIV (PLWH) with detectable virus levels.\n\nThe main goals of this study are:\n\n* To learn about the safety of BNT351 and check for side effects.\n* To measure the amount of BNT351 antibody in blood over time.\n* To test the amount of HIV in the blood at different times after treatment with BNT351 in people living with HIV.",[28],[293,294,295],"HIV-1","Treatment of HIV-1 infection","Antibody","2026-06-18",{"date":271,"type":38},{"date":299,"type":38},"2026-02-09",{"date":301,"type":22},"2027-06",{"name":44,"class":45},6,{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},"100604271","phase-1-a-first-in-human-dose-escalation-and-indication-expansion-study-of-bnt3212-as-monotherapy-or-in-combination-with-bnt327-in-adults-with-advanced-solid-tumors-100604271","NCT07147348","A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors","A Phase I\u002FII, First-in-human, Open-label, Dose Escalation and Indication Expansion Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Participants with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors that have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease; or for whom the standard therapy is considered inappropriate or intolerable.\n* Have at least one measurable lesion based on RECIST v1.1.\n* Eastern Cooperative Oncology Group performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature).\n* Predicted life expectancy of ≥3 months.\n* Left ventricular ejection fraction ≥50% by either echocardiography or multigated acquisition scan within 28 days prior to first dose of study treatment.\n* Adequate liver, renal, hematological, and coagulation function.\n* Recovery to Grade 0-1 (or baseline) from adverse reactions related to prior anti cancer therapy except for:\n\n  * Asymptomatic laboratory abnormalities such as elevated alkaline phosphatase, hyperuricemia, elevated serum amylase\u002Flipase, and elevated blood glucose.\n  * Toxicity that the investigator determined to have no safety risk, such as alopecia, Grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.\n* The investigator considers discontinuation of protocol-defined anti-cancer therapies and restricted medications with protocol-defined washout periods as medically acceptable.\n* For Parts B and D only: Participants must be diagnosed with specific indications.\n\nKey Exclusion Criteria:\n\n* Active infection (e.g., bacterial or fungal infections) requiring systemic treatment (e.g., severe pneumonia, bacteremia, sepsis), except oral antibiotics.\n* Participants with primary central nervous system (CNS) malignancies.\n* Active CNS metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n* Unstable pleural effusion or ascites requiring thoracentesis or paracentesis within 14 days prior to initiation of study treatment.\n* Have active, or a history of, pneumonitis requiring treatment with steroids, or has active, or a history of, interstitial lung disease.\n* Clinically significant pulmonary complications.\n* History of severe cardiovascular disease.\n* Have a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent\u002Fpersistent Grade 3 to 4 neutropenia.\n* Have active or chronic corneal disorders or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.\n* Have uncontrolled hypertension while on antihypertensive medicine or poorly controlled diabetes.\n* Concurrent malignancy within 5 years prior to study enrollment. Exceptions: basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ after radical resection.\n* Unstable thrombotic event (e.g., deep vein thrombosis, arterial thrombosis, pulmonary embolism).\n* Have adverse reactions from prior anti-tumor therapy that have not returned to Grade 1 (graded by NCI CTCAE v5.0 criteria) or below (unless the investigator determines that certain AEs pose no safety risk to participants, such as hair loss, Grade 2 peripheral neuropathy or stable hypothyroidism under hormone replacement therapy) are not eligible for the study.\n* For Parts C and D only: Prior treatment with PD-1\u002FL1 and VEGF-A antibody combinations (including bispecific antibodies to PD-1\u002FL1 and VEGF-A).\n* For Parts C and D only: Have active, or history of, autoimmune disease with risk of exacerbation following PD-L1 inhibition OR an immune deficiency (e.g., allogeneic hematopoietic stem cell transplantation or organ transplantation). Participants with protocol-specified conditions may be eligible.\n* For Parts C and D only: Have serious non-healing wounds, ulcer, or bone fracture.\n* For Parts C and D only: Have evidence of major coagulation disorders or other significant risks of hemorrhage.\n* For Parts C and D only: Have a history of serious Grade 3 or higher immune-related adverse events that led to treatment discontinuation of a prior immunotherapy.\n* For Parts C and D only: Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.\n* For Parts C and D only: Have received:\n\n  * Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) within 14 days prior to the first dose of IMP.\n  * Antiplatelet drugs within 10 days prior to the initiation of study treatment.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":312,"type":22},375,[25,56],"The aim of this first-in-human (FIH) open-label, multi-site study is to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy of BNT3212, including identification of the recommended dose of BNT3212 for use as monotherapy and with pumitamig (also known as BNT327 or PM8002) as combination therapy, in adults with advanced solid tumors who have exhausted other treatment options.",[316],"Advanced Solid Tumor",[318,101,63,319,65,186,99,66,295,320],"BNT3212 (or PM1300)","Vascular endothelial growth factor A (VEGF-A)","Programmed death 1 (PD-1)","2026-06-12",{"date":323,"type":38},"2026-06-15",{"date":325,"type":38},"2025-08-27",{"date":327,"type":22},"2028-08",{"name":44,"class":45},17,{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":359},"100598341","phase-1-a-clinical-study-to-test-if-an-investigational-treatment-called-bnt326-is-safe-and-potentially-beneficial-when-used-alone-or-in-combination-with-other-investigational-treatments-such-as-bnt327-for-people-with-advanced-malignant-tumors-100598341","NCT07070232","A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors","A Phase I\u002FII, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced Solid Tumors","Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified):\n\n* Aged ≥18 years at the time of giving informed consent. Local laws will be followed if the age of consent is older.\n* Have histologic or cytologic documented advanced disease, either at relapse or upon diagnosis of metastatic disease. This requirement may be considered met when advanced disease derives from unequivocal progression of a previously biopsied site of disease (e.g., progression of residual tumor after concomitant chemo-radiation for Stage III NSCLC).\n* Have measurable disease defined by RECIST v1.1.\n* All participants must provide a tumor tissue sample (Formalin-fixed paraffin-embedded \\[FFPE\\] slides) from archival tissue. The archival tissue can be an FFPE block or freshly cut slides derived from the advanced setting or a new\u002Ffresh tumor biopsy.\n* Have ECOG performance status of 0 or 1.\n* Have adequate organ and bone marrow function (as specified in the protocol) within 7 days before randomization\u002Fenrollment.\n* Cohort 1A:\n\n  * Have histologically or cytologically confirmed diagnosis of unresectable or metastatic cutaneous melanoma not amenable to local therapy.\n  * Participants must have previously received a PD-1 or PD-L1 inhibitor, and, for participants with human gene that encodes a protein called B-Raf (BRAF) gene mutant melanoma, a prior treatment regimen that included vemurafenib, dabrafenib, or another BRAF gene inhibitor with or without mitogen-activated protein kinase protein inhibitor, if available and clinically indicated per local standard of care (SoC) and have experienced progression during or after the previous treatment or discontinued from prior therapy due to intolerance.\n* Cohort 1B and 1C: Have advanced (i.e., metastatic or locally recurrent where local therapy with curative intent is not possible) non-squamous or squamous NSCLC.\n* Cohort 1B:\n\n  * Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase rearrangements, or other genomic alterations for which targeted molecular therapies are available. For enrolled participants with predominantly squamous histology tumors, molecular testing will not be required in cases where it is not part of the SoC.\n  * Have experienced relapse or progression during or after treatment with standard systemic therapy including platinum-based chemotherapy and\u002For immune checkpoint inhibitor in the advanced\u002Fmetastatic setting or discontinued from prior therapy due to intolerance.\n  * Participants must have received 1 to 3 lines of systemic treatment, which can include anti-PD-1\u002FPD-L1 therapy (if PD-L1 positive), chemotherapy, and anti-angiogenic agents. These treatments may be administered concurrently or sequentially. Prior chemotherapy must be limited to 2 lines or less.\n* Cohort 1C:\n\n  * Have documented positive test results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del).\n  * Participants must have received one or two prior lines of systemic therapy for advanced and\u002For metastatic disease, which must include treatment with an approved EGFR Tyrosine Kinase Inhibitors (TKI), with at least one being a third-generation EGFR TKI. If there is no third-generation EGFR TKI approved as part of SoC by local health authorities in a certain country, failure\u002Fprogression on any EGFR TKI is acceptable for eligibility.\n  * Participants receiving an EGFR TKI at the time of signing informed consent may continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1.\n  * Prior chemotherapy and amivantamab are permitted only if administered in combination with an EGFR TKI as part of a single line of therapy and as the initial (first line) treatment for advanced\u002Fmetastatic disease. Participants must not have received any other systemic therapies (such as chemotherapy, immunotherapy, or targeted agents) for advanced\u002Fmetastatic disease, unless those treatments were given in combination with an EGFR TKI.\n  * Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.\n* Cohort 1D:\n\n  * Have histologically or cytologically confirmed diagnosis of unresectable or metastatic acral\u002Fuveal\u002Fmucosal melanoma not amenable to local therapy.\n  * Participants must have:\n\n    * Previously been treated with a PD-1 or PD-L1 inhibitor, if clinically indicated and available per local SoC, and\u002For\n    * For participants with Human Leukocyte Antigen Alleles (HLA-A)\\*02:01 serotype-positive disease (only applicable for uveal melanoma), previously been treated with tebentafusp-tebn if clinically indicated and available per local SoC, and\n    * Experienced progression during or after the previous treatment or discontinued from prior therapy due to intolerance.\n* Cohorts 1E and 1F (DDI):\n\n  * Have histologically or cytologically confirmed diagnosis of unresectable or metastatic advanced solid tumor not amenable to ablative or curative approach including, but not limited to:\n\n    * Cholangiocarcinoma, including tumors of the intra- and extrahepatic biliary tract and gallbladder\n    * Hepatocellular carcinoma (HCC).\n    * Renal cell carcinoma\n    * Endometrial carcinoma, excluding those classified as true sarcomas\n    * Pancreatic ductal adenocarcinoma (PDAC) (see below other related inclusion criterion)\n    * Neuroendocrine tumor of pancreatic, gastrointestinal, lung, and thymus that is well differentiated, Grade 1 to 3.\n    * NSCLC (Cohort 1F only)\n  * Have experienced disease progression on at least one and no more than three lines of prior therapy or, for Cohort 1E only, discontinued from prior therapy due to intolerance.\n  * (For participants with PDAC only) Have received one or two lines of systemic therapy for metastatic tumors, and have experienced progression or intolerance to the treatment during or following therapy.\n* Cohort 2A: Have histologically or cytologically confirmed diagnosis of unresectable or metastatic cutaneous melanoma not amenable to local therapy.\n* Cohort 2B: Have histologically or cytologically confirmed diagnosis of recurrent unresectable or metastatic breast cancer that is documented as HER2-negative and either HR-negative or HR-positive per American Society of Clinical Oncology\u002FCollege of American Pathologists guidelines.\n* Cohort 2D:\n\n  * Histologically and\u002For cytologically documented metastatic adenocarcinoma and squamous carcinoma of GC\u002FGEJC. (Note: ESCC is excluded).\n  * (2L subgroup): Had disease progression during or after one prior line of anti-cancer therapy for recurrent\u002Fmetastatic disease.\n  * (3L subgroup): Has received two or more lines of prior anti-cancer therapy for recurrent\u002Fmetastatic disease.\n  * (HER2-expression positive subgroup): Has received at least one prior line of systemic therapy for recurrent or metastatic disease, including a HER2-targeted agent in accordance with local SoC.\n* Cohort 2E:\n\n  * Histologically and\u002For cytologically documented recurrent unresectable metastatic colorectal adenocarcinoma.\n  * Must have received at least one line to a maximum of three lines of prior SoC treatment for recurrent\u002Fmetastatic disease.\n* Cohort 1G and 2F:\n\n  * Histologically and\u002For cytologically documented recurrent unresectable metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology.\n  * Must have received platinum-based chemotherapy, with or without an anti-PD-(L)1 agent and bevacizumab for metastatic\u002Frecurrent disease, unless the patient is not a candidate in the opinion of the treating physician.\n\nKey Exclusion Criteria (applicable to all participants and all parts unless otherwise specified):\n\n* Have a history of intolerance to treatment with a topoisomerase I inhibitor or intolerance to an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and deruxtecan (e.g., severe diarrhea).\n* Have an uncontrolled concomitant or intercurrent illness that contra-indicates study participation, limits compliance with study procedures or substantially increases the risk of incurring adverse events, including:\n\n  * Bleeding diathesis or active hemorrhage,\n  * Active infection,\n  * Child-Pugh class B or C cirrhosis,\n  * Pulmonary disease with significant impact in lung function\n  * Oncologic emergencies or complications (e.g., malignant hypercalcemia, superior vena cava syndrome, carcinoid syndrome that is unstable and with available alternative therapies),\n  * Psychiatric or abuse condition\n  * Infectious colitis Grade ≥2 not resolved to Grade 1 within 72 hours within the past 3 months.\n* Have LVEF \\\u003C50% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization\u002Fenrollment.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization\u002Fenrollment.\n* Have a history of (non-infectious) interstitial lung disease (ILD) \u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening. Asymptomatic interstitial changes caused by previous radiation therapy, chemotherapy, or other factors such as smoking are acceptable.\n* Are a participant of child-bearing potential who are pregnant or breastfeeding or are planning pregnancy within 225 days (\\~7.5 months) after receiving last dose of BNT326 and within 6 months after last dose of BNT327, whichever is longer.\n* Are potentially fertile males, who are planning to father children during the study or within 135 days (\\~4.5 months) after the last dose of BNT326 and within 6 months after last dose of BNT327, whichever is longer.\n* Are subject to exclusion periods from another investigational study.\n* Specific to BNT327: Participants with significant risks of hemorrhage or evidence of major coagulation disorders as specified in the protocol.\n* Specific to BNT327: Have a history of intolerance to treatment with an anti-VEFG, anti-PD-1\u002FPDL-1, or similar substance, including, but not limited to, bevacizumab, ramucirumab, atezolizumab, pembrolizumab, nivolumab, or other related therapies.\n* Cohort 1E: Have histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":338,"type":22},980,[25,56],"This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and\u002For have relapsed\u002Fprogressed after prior therapy.",[316],[99,63,186,343,268,130,67,270,65,66,68,344,240,345,346,347,348,349,350],"Human epidermal growth factor receptor 3 (HER3)","Time to progression","Cutaneous Melanoma","Rare melanoma","Actionable oncogenic alterations (AGA)-negative non-small cell lung cancer (NSCLC)","Epithelial growth factor receptor mutated (EGFRm) NSCLC","Gastric cancer (GC)","Gastroesophageal junction cancer (GEJC)","2026-05-21",{"date":353,"type":38},"2026-05-22",{"date":355,"type":38},"2025-08-12",{"date":357,"type":22},"2029-10",{"name":44,"class":45},64,{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":370,"briefSummary":371,"conditions":372,"keywords":376,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":397},"100403507","phase-2-a-clinical-trial-investigating-the-safety-tolerability-and-therapeutic-effects-of-bnt113-in-combination-with-pembrolizumab-versus-pembrolizumab-alone-for-patients-with-a-form-of-head-and-neck-cancer-positive-for-human-papilloma-virus-16-and-expressing-the-protein-pd-l1-100403507","NCT04534205","A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1","An Open-label Phase II\u002FIII Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1","AHEAD-MERIT","Key Inclusion Criteria:\n\n* Patients must sign the written pre-screening informed consent form (ICF) before any pre-screening procedures.\n* Patients who present histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies.\n* Patients who have a tumor that expresses PD-L1 \\[CPS ≥1\\] as determined by the European Conformity (CE)-marked\u002FFood and Drug Administration-approved CDx PD-L1 immunohistochemistry 22C3 pharmDx performed according to the manufacturer's instructions for use.\n* Patients must not have had prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting. Systemic therapy which was completed more than 180 days prior to randomization, if given as part of multimodal treatment for locally advanced disease, is allowed.\n* Patients who have measurable disease based on RECIST 1.1 as determined by the site and confirmed by BICR. Tumor lesions situated in a previously irradiated area may be considered measurable, if progression has been demonstrated in such lesions disease by RECIST 1.1.\n* All patients must provide a tumor tissue sample (formalin fixed paraffin embedded \\[FFPE\\] blocks or both slides and curls) from archival tissue. Alternatively, a fresh biopsy sample could be provided if a biopsy sample is performed as part of the patient's standard clinical practice before the first dose of trial treatment. The sample should be preferably derived from a current site of metastatic or recurrent disease. Otherwise, a sample from the primary tumor can be submitted.\n\nKey Exclusion Criteria:\n\nMedical conditions:\n\n* Patients present primary tumor site of nasopharynx (any histology).\n* Patients with another primary malignancy that has not been in complete remission for at least 2 years, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, non-invasive basal or non-invasive squamous cell skin cancer, localized prostate cancer, non-invasive superficial bladder cancer or breast ductal carcinoma in situ).\n\nPrior\u002Fconcomitant therapy:\n\n* Patients who have received or currently receive the following therapy\u002Fmedication:\n\n  1. Chronic systemic immunosuppressive treatment including corticosteroid treatment (prednisone \\>10 mg daily orally \\[PO\\] or intravenously \\[IV\\], or equivalent) in the 7 days prior to the first dose of trial treatment.\n  2. Prior treatment with other immune-modulating agents that was (a) within fewer than 4 weeks (28 days) or five half-lives of the agent (whichever is longer) prior to the first dose of BNT113, or (b) associated with immune-mediated AEs that have not resolved prior to the first dose of BNT113 or that pose an additional risk of on-trial complications, per investigator's assessment, or c) associated with toxicity that resulted in discontinuation of the immune-modulating agent and that poses an additional risk of on-trial complications, per investigator's assessment.\n  3. Prior treatment with live attenuated vaccines within 4 weeks before the first dose of BNT113.\n  4. Prior treatment with an investigational drug (including investigational vaccines) within 4 weeks or five half-lives of the agent (whichever is longer) before the planned first dose of BNT113.\n  5. Ongoing treatment with therapeutic PO or IV antibiotics. Note: Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) may be enrolled.\n* Prior treatment with anti-cancer immunomodulating agents, such as blockers of programmed death receptor-1 (PD-1), PD-L1, tumor necrosis factor receptor superfamily member 9 (TNRSF9, 4 1BB, CD137), OX 40, therapeutic vaccines, cytokine treatments, or any investigational agent within 4 weeks or five half-lives of the agent (whichever is longer) before the first dose of BNT113.\n* Treatment with non-systemic anti-cancer therapy (e.g., radiotherapy or surgery) within 2 weeks prior to randomization. Note: Prior treatment with bone resorptive therapy, such as bisphosphonates (e.g., pamidronate, zoledronic acid) and denosumab, is allowed.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":369,"type":22},350,[56,89],"An open-label, controlled, multi-site, interventional, 2-arm, Phase II\u002FIII trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1.\n\nThis trial has two parts.\n\nPart A, is an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.\n\nPart B, is a randomized part to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. Patients included in the Safety Run-In Phase of the trial (Part A) will not be randomized to Part B and will continue on-trial treatment (BNT113 plus pembrolizumab) within Part A.\n\nFor Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial.\n\nPatients will be treated with BNT113 in combination with pembrolizumab or with pembrolizumab monotherapy for approximately up to 24 months.",[373,374,375],"Unresectable Head and Neck Squamous Cell Carcinoma","Metastatic Head and Neck Cancer","Recurrent Head and Neck Cancer",[377,378,379,380,381,382,383,384,385,386,387,388,389],"Cancer vaccine","RNA vaccine","HNSCC","BNT113","Pembrolizumab","HPV16","Metastatic","Unresectable","Recurrent","Head and neck","mRNA vaccine","HPV-positive","Head and neck cancer","2026-05-20",{"date":353,"type":38},{"date":393,"type":38},"2021-01-07",{"date":395,"type":22},"2029-04",{"name":44,"class":45},195,{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},"100627984","phase-1-early-phase-trial-to-assess-the-safety-and-preliminary-efficacy-of-bnt3214-in-adults-with-advanced-solid-tumors-100627984","NCT07455734","Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors","A Phase I\u002FIIa, First-in-human, Open-label, Multi-site, Multi-regional, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants aged ≥18 years of age inclusive at the time of giving informed consent.\n* Have at least one measurable tumor lesion based on RECIST v1.1. One lesion with prior local treatment (i.e., radiotherapy) can be considered measurable only if a disease progression from prior local treatment was demonstrated in the lesion per RECIST v1.1.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have a predicted life expectancy ≥3 months.\n* Have histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors that have progressed after at least one available standard therapy; or for whom the standard therapy is considered to be ineffective, inappropriate or intolerable; or for whom a clinical study of an investigational agent is a recognized standard of care.\n* Have adequate liver function as defined in the protocol.\n* Have adequate renal function as defined in the protocol.\n* Have adequate hematologic function as defined in the protocol.\n* Have adequate coagulation as defined in the protocol.\n\nExclusion Criteria:\n\n* Untreated or symptomatic central nervous system (CNS) metastases and leptomeningeal disease.\n* Have a primary CNS malignancy.\n* Have active, or a history of, pneumonitis requiring treatment with steroids, or have active, or a history of, interstitial lung disease.\n* Have clinically significant pulmonary complications including, but not limited to, chronic obstructive pulmonary disease, restrictive lung disease, lung injury accompanied with autoimmune disease\u002Fconnective tissue disorders.\n* Have a history of severe cardiovascular disease.\n* Have a history of significant hematologic toxicity to prior lines of therapy, as assessed by the investigator.\n* Have uncontrolled hypertension or poorly controlled diabetes prior to allocation or randomization.\n* Have concurrent malignancy within 5 years prior to allocation or randomization (protocol defined exceptions apply).\n* Have unstable thrombotic event (e.g., deep vein thrombosis, arterial thrombosis, pulmonary embolism) requiring therapeutic intervention within 3 months prior to allocation or randomization, unless the participant has been fully treated (e.g., inferior vena cava filter placed) and\u002For adequately anticoagulated on a prophylactic dose.\n* Have known human immunodeficiency virus infection or known acquired immunodeficiency syndrome (protocol defined exceptions apply).\n* Have an active hepatitis B virus infection.\n* Have an active hepatitis C virus (HCV) infection. Participants with a negative HCV antibody test at screening or positive HCV antibody test followed by a negative HCV ribonucleic acid test at screening are eligible. Participants who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed.\n* Have adverse reactions from prior anti-tumor therapy that have not returned to Grade ≤1, except for alopecia or toxicities (not specified elsewhere) considered irreversible and posing no safety risk to participants.\n* Have active, or history of, autoimmune disease (e.g., myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, vasculitis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis) (protocol defined exceptions apply).\n* Have serious non-healing wounds, ulcer, or bone fracture.\n* Participants with lung cancer who have major coagulation disorders or an increased risk of hemorrhage (per investigator's clinical judgment)\n* Have a history of serious Grade ≥3 immune-related adverse events (irAEs) that led to treatment discontinuation of a prior immunotherapy. Participants with a history of Grade ≥3 irAEs that did not lead to treatment discontinuation of a prior immunotherapy should be evaluated and determined by investigators for potential safety risk.\n* Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to allocation or randomization.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment (protocol defined exceptions apply).\n* Have received any of the following therapies or drugs within the noted time intervals prior to allocation or randomization:\n\n  * Systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 10 days prior to the initiation of study treatment.\n  * Have been vaccinated with live, attenuated vaccine(s) within 4 weeks prior to initiation of the study treatment.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":406,"type":22},533,[25,56],"This study is the first time the drug BNT3214 (also referred to as PM8102) will be tested in people. It is designed to find out if the drug is safe and how well it works for adults with advanced solid tumors. The study will have three parts. The first two parts (Parts A and B) will focus on testing different amounts of BNT3214 to figure out the best and safest dose. The third part (Part C) will test selected doses of BNT3214 in multiple types of cancer.",[410],"Advanced Solid Tumor Cancer",[412,65,62],"Advanced solid tumors","2026-05-13",{"date":415,"type":38},"2026-05-14",{"date":417,"type":38},"2026-03-30",{"date":419,"type":22},"2030-10",{"name":44,"class":45},5,{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":452},"100607306","phase-1-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-ca19-9-100607306","NCT07186842","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","Key Inclusion Criteria\n\nAll participants and parts:\n\n* Have an ECOG PS of 0 to 1\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), 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, 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* Have received at least one prior systemic treatment regimen for advanced\u002Fmetastatic disease. Participants who have progressed on \\\u003C6 months of (neo)adjuvant chemotherapy can be included in the study.\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 requires 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 may apply.",{"count":430,"type":22},245,[25,56],"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.",[434],"Advanced Solid Cancers",[436,437,438,439,440,441,442,443,444],"CA19-9","Anti-drug conjugate (ADC)","Pancreatic ductal adenocarcinoma","Bile duct cancer","Colorectal cancer","Gastroesophageal junction cancer","Endometrial cancer","Ovarian cancer","Invasive urothelial carcinoma of the bladder and urinary tract","2026-05-12",{"date":413,"type":38},{"date":448,"type":38},"2025-11-18",{"date":450,"type":22},"2030-05",{"name":44,"class":45},10,{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":463,"conditions":464,"keywords":465,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":474},"100601517","phase-1-a-clinical-trial-to-test-if-an-investigational-combination-therapy-with-bnt326-and-bnt327-is-safe-and-potentially-beneficial-for-people-with-advanced-non-small-cell-lung-cancer-nsclc-100601517","NCT07111520","A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)","A Phase Ib\u002FII, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination With BNT327 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)","Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified):\n\n* Aged ≥18 years at the time of giving informed consent.\n* Have measurable disease defined by RECIST v1.1.\n* All participants have to provide a tumor tissue sample (e.g. Formalin-fixed paraffin-embedded \\[FFPE\\] slides or block) from archival tissue. Alternatively, a fresh biopsy should be collected, unless medically not justifiable to be conducted.\n* Have Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have adequate organ and bone marrow function within 7 days before randomization\u002Fenrollment.\n* Have advanced (i.e., metastatic or locally recurrent where local therapy with curative intent is not possible) non-squamous or squamous (all cohorts) or only non-squamous (Cohort D2) NSCLC.\n\nCohort-specific inclusion criteria\n\nPart 1, 2L+, squamous or non-squamous NSCLC, AGA-negative\u002Fpositive, any PD-L1\n\n* for AGA-negative NSCLC only:\n\n  * Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.\n  * Have experienced relapse or progression during or after treatment with standard systemic therapy in the advanced\u002Fmetastatic setting or discontinued from prior therapy due to intolerance.\n  * Participants must have received 1 to 3 lines of systemic treatment, which can include anti-PD-1\u002FPD-L1 therapy, chemotherapy, and anti-angiogenic agents. These treatments may be administered concurrently or sequentially. However, chemotherapy treatment must be limited to 2 lines or less.\n* for AGA-positive NSCLC only (excluding EGFR activating mutation):\n\n  * Have documented positive test results for one or more actionable genomic alteration: EGFR (other than activating mutations), ALK, ROS proto-oncogene 1 (ROS1), gene encoding the hepatocyte growth factor receptor (MET), human gene that encodes a protein called B-Raf (BRAF), rearranged during transfection (RET), neurotrophic tropomyosin-receptor kinase (NTRK), human epidermal growth factor receptor 2 (HER2), Kirsten rat sarcoma virus (KRAS), or other genomic alteration with available targeted therapy.\n  * Must have received at least one prior systemic therapy for advanced disease, which must have included targeted treatment for actionable genomic alterations, which include alterations such as EGFR (other than activating mutations), ALK, ROS1, MET, BRAF, RET, NTRK, HER2, KRAS, or other alterations for which targeted therapies are available as a part of local SoC.\n  * Participants may have received between 1 to 3 lines of systemic treatment of anti-PD-1\u002FPD-L1 therapy, chemotherapy, and\u002For anti-angiogenic agents. These treatments may be administered concurrently (including with TKI) or sequentially. However, chemotherapy treatment must be limited to 2 lines or less.\n  * Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.\n* for AGA-positive NSCLC only (with EGFR activating mutation):\n\n  * Have documented positive test results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del).\n  * Participants must have received one or two prior lines of systemic therapy for advanced and\u002For metastatic disease, which must include treatment with an approved EGFR TKI, with at least one being a third-generation EGFR TKI.\n  * Participants receiving an EGFR TKI at the time of signing informed consent may continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1.\n  * Chemotherapy is permitted only if it was administered in combination with an EGFR TKI as part of a single line of therapy and as the initial (first line) treatment for advanced\u002Fmetastatic disease.\n  * Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.\n\nPart 2a (Cohort A), 2L+, squamous or non-squamous NSCLC, AGA-negative\u002Fpositive, any PD-L1\n\n* for AGA-positive NSCLC only, excluding EGFR activating mutation:\n\n  * Have documented positive test results for one or more actionable genomic alterations: EGFR (other than activating mutations), ALK, ROS1, MET, BRAF, RET, NTRK, HER2, KRAS, or other genomic alterations, with available targeted therapy.\n  * May have received 1 to 4 lines of systemic treatment, of which one prior systemic therapy for advanced disease must have included targeted treatment for actionable genomic alterations, which include alterations such as EGFR (other than activating mutations), ALK, ROS1, MET, BRAF, RET, NTRK, HER2, KRAS, or other genomic alterations for which targeted therapies are available as part of local SoC.\n  * Other therapies may include anti-PD-1\u002FPD-L1 therapy, chemotherapy, and anti-angiogenic agents. These treatments may be administered concurrently\u002Fin combination (including with TKI) or sequentially. However, chemotherapy treatment must be limited to 2 lines or less.\n  * Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.\n* for AGA-positive NSCLC only, with EGFR activation mutation:\n\n  * Have documented positive test results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del).\n  * Participants must have received one or two prior lines of systemic therapy for advanced and\u002For metastatic disease, which must include treatment with an approved EGFR TKI, with at least one being a third-generation EGFR TKI.\n  * Participants receiving an EGFR TKI at the time of signing informed consent may continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1.\n  * Chemotherapy is permitted only if it was administered in combination with an EGFR TKI as part of a single line of therapy and as the initial (first line) treatment for advanced\u002Fmetastatic disease.\n  * Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.\n\nPart 2a (Cohort B), 1L, squamous or non-squamous NSCLC, AGA-negative, any PD-L1\n\n* Have no actionable genomic alterations, such as EGFR mutations, ALK rearrangements, or other genomic alterations for which targeted molecular therapies are available.\n* Have received no systemic anti-cancer treatment in the advanced\u002Fmetastatic setting. May have received neoadjuvant and\u002For adjuvant treatment if progression to advanced\u002Fmetastatic disease occurred at least 12 months after completing such therapy and have not received treatment in the advanced\u002Fmetastatic setting.\n\nPart 2b (Cohort C), 2L+, squamous or non-squamous NSCLC, AGA-negative or EGFR activating mutation, any PD-L1\n\n* for AGA-negative NSCLC only:\n\n  * Have no actionable genomic alterations, such as EGFR mutations, ALK rearrangements, or other genomic alterations for which targeted molecular therapies are available.\n  * Participants should have received 1 to 4 lines of systemic treatment, which can include anti-PD-1\u002FPD-L1 therapy, chemotherapy, and\u002For anti-angiogenic agents.\n* for EGFR-sensitizing mutation NSCLC only:\n\n  * Have documented positive test results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del).\n  * Have received 1 or 2 prior systemic therapies for advanced and\u002For metastatic disease with an approved EGFR TKI, which must include one third-generation anti-EGFR TKI.\n  * Participants receiving an EGFR TKI at the time of signing informed consent may continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1.\n  * Chemotherapy is permitted only if it was administered in combination with an EGFR TKI as part of a single line of therapy and as the initial (first line) treatment for advanced\u002Fmetastatic disease.\n  * May have received neoadjuvant and\u002For adjuvant treatment if progression to advanced\u002Fmetastatic disease occurred at least 6 months after completing such therapy and have experienced disease progression on or after EGFR TKI treatment administered in the advanced\u002Fmetastatic setting.\n  * Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.\n\nPart 2b (Cohort D1) 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50% and Part 2b (Cohort D2) 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 \\\u003C50%\n\n* Have no actionable genomic alterations, such as EGFR mutations, ALK rearrangements, or other genomic alterations for which targeted molecular therapies are available.\n* Did not receive prior systemic therapy for advanced and\u002For metastatic disease.\n\nKey Exclusion Criteria (applicable to all participants and all parts):\n\n* Had disease progression on or were intolerant to prior treatment with an agent targeting HER3 (including antibody, ADC, cell therapy, and other drugs) or with a topoisomerase I inhibitor payload (including topoisomerase I inhibitor-containing ADCs). Note: For Part 2a Cohort A, prior exposure to agents targeting HER3 or topoisomerase I inhibitor payload may be allowed on a case-by-case basis after discussion with and approval by the sponsor.\n* Have an uncontrolled concomitant or intercurrent illness, that contra-indicates study participation, limits compliance with study procedures or substantially increases the risk of incurring AEs, including:\n\n  * Bleeding diathesis or active hemorrhage\n  * Active infection, including respiratory viral infection\n  * Child-Pugh class B or C cirrhosis\n  * Known pulmonary disease with significant impact in lung function and\u002For with potential risk of severe infection\n  * Oncologic emergencies or complications (e.g., malignant hypercalcemia, superior vena cava syndrome, carcinoid syndrome that is unstable and with available alternative therapies)\n  * Psychiatric or abuse condition\n  * Colitis Grade ≥2 not resolved within 72 h within the past 3 months\n* Have left ventricular ejection fraction \\\u003C50% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization\u002Fenrollment.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization\u002Fenrollment.\n* Have a history of (non-infectious) interstitial lung disease (ILD) \u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening. Asymptomatic interstitial changes caused by previous radiation therapy, chemotherapy, or other factors such as smoking are acceptable.\n* Have had exposure to protocol-specific treatments with a washout period before randomization\u002Fenrollment.\n* Are participants of childbearing potential who are pregnant or breastfeeding or are planning pregnancy within the time specified in the protocol or are potentially fertile males, who are planning to father children during the study or within the time specified in the protocol.\n* Are subject to exclusion periods from another investigational study.\n* Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.\n* Have urine protein ≥2+ and 24-hour urine protein excretion ≥1 g. If qualitative urine protein is ≤1+, a 24-hour urine protein quantitative test is not required.\n* Have a history of Grade ≥3 immune-related adverse events that led to treatment discontinuation of a prior checkpoint inhibitor.\n* Have clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n* Participants with significant risks of hemorrhage or evidence of major coagulation disorders.\n* Have active or chronic corneal disorders or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":461,"type":22},420,[25,56],"This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with BNT327 in participants with relapsed, progressive as well as treatment-naïve, advanced\u002Fmetastatic non-small cell lung cancer (NSCLC).\n\nThis study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available).",[126],[99,63,186,343,268,130,67,270,65,66,68,344,240],"2026-04-29",{"date":468,"type":38},"2026-05-05",{"date":470,"type":38},"2025-09-22",{"date":472,"type":22},"2030-01",{"name":44,"class":45},68,{"id":476,"slug":477,"hasResults":11,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":482,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":485,"briefSummary":486,"conditions":487,"keywords":489,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":303},"100615792","phase-2-a-clinical-trial-testing-the-safety-of-the-investigational-drug-pumitamig-bnt327-and-how-well-it-works-in-patients-with-recurrent-glioblastoma-100615792","NCT07297212","A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma","A Phase II, Multi-site, Open-label Trial Evaluating the Safety and Efficacy of Pumitamig and Bevacizumab as Monotherapy and Pumitamig in Combination With Temozolomide in Patients With Recurrent Glioblastoma","Key Inclusion Criteria:\n\n* Adults, aged 18-75 years inclusive at the time of giving informed consent. Local laws will be followed if the age at consent is older.\n* Have a histologically confirmed diagnosis of WHO Grade IV GBM, IDH-wildtype consistent with WHO CNS 2021 criteria.\n* Have recurrent supratentorial GBM who have received prior treatment with at least radiotherapy and temozolomide.\n* Have first recurrence documented by magnetic resonance imaging (MRI), with an interval of at least 12 weeks after the end of prior radiotherapy unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field.\n* Have been clinically evaluated as having relapsed or progressed disease with at least one measurable lesion as the targeted lesion based on RANO 2.0 criteria.\n* Have KPS ≥60.\n* Can swallow the medication and maintain oral administration.\n* Have a baseline brain MRI, not more than 14 days before starting the study treatment.\n* Have a stable dose of steroids ≥7 days before the contrast-enhanced scan.\n* Have adequate organ function, as defined in the protocol.\n\nKey Exclusion Criteria:\n\n* Have received any of the following therapies or drugs before study enrollment:\n\n  * Any anticancer therapies, including systemic, palliative, biologic, immunostimulatory, or immunosuppressive treatment within 4 weeks (or five half-lives, whichever is longer) before starting the study treatment.\n  * PD(L)-1\u002FVEGF bispecific antibodies, cluster of differentiation (CD)137 agonists or other immune checkpoint blockade therapies including monotherapy with either category or combinations thereof.\n  * Systemic corticosteroids (at a dosage greater than 2 mg\u002Fday of dexamethasone or an equivalent dose of other corticosteroids) within 7 days before starting the study treatment.\n  * Vaccinations with live attenuated vaccine(s) within 4 weeks before starting the study treatment.\n  * Broad-spectrum intravenous antibiotics therapy within 2 weeks before starting the study treatment.\n  * Any non-study investigational medicinal product within five half-lives of the first dose or within 4 weeks, whichever is longer, before starting the study treatment in this study or ongoing participation in the active treatment phase of another interventional clinical study.\n  * Antiplatelet drugs, such as aspirin (\\>325 mg\u002Fday), clopidogrel (\\>75 mg\u002Fday), dipyridamole, ticlopidine or cilostazol, etc., within 10 days before starting the study treatment to avoid inclusion of participants who have used platelet aggregation inhibitors before the study.\n* Have had more than one recurrence of GBM.\n* Are allergic to dacarbazine and temozolomide.\n* Have known leptomeningeal disease, extracranial disease, or multicentric disease.\n* Have been diagnosed with secondary GBM (i.e., glioblastomas that progress from low grade diffuse astrocytoma or anaplastic astrocytoma).\n* Have previously received radiotherapy with anything other than standard radiotherapy (i.e., focally directed radiation).\n* Have received prior interstitial brachytherapy, interstitial thermal therapy, implanted chemotherapy, or therapeutics delivered by local injection or convection-enhanced drug delivery. Participants who had prior treatment with Gliadel® wafers and who had concurrent use of devices such as Tumor Treating Fields are excluded.\n* Have uncontrolled hypertension or poorly controlled diabetic conditions as specified in the protocol before study enrollment.\n* Are unable (due to existent medical condition, e.g., pacemaker or implantable cardioverter defibrillator device) or unwilling to have a head contrast-enhanced MRI.\n* Have undergone major surgery, open biopsy, or significant traumatic injury within 28 days before starting the study treatment, or a planned\u002Fanticipated need for major surgery during the study treatment period. Placement of vascular infusion devices is allowed. Note: If participant has had major surgery, they must have recovered adequately from the toxicity and\u002For complications from the treatment prior to the initiation of study treatment.\n* Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.\n* Have had other malignant tumors within 5 years before starting the study treatment. Exception: those who have been cured with local treatment (such as basal cell or squamous-cell carcinoma of the skin, superficial or noninvasive bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of thyroid and early-stage prostate cancer).\n* Have any of the following heart conditions within 6 months before starting the study treatment:\n\n  * Myocardial infarction, unstable angina, acute coronary syndrome, coronary artery bypass grafting, congestive heart failure, aortic dissection, stroke, cerebrovascular accident or other Grade 3 and above cardiovascular events.\n  * New York Heart Association functional classification ≥II heart failure or left ventricular ejection fraction \\\u003C50%.\n  * Ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, or congenital long QT syndrome. Participants with stable treated cardiac arrythmia\u002Fatrial fibrillation are allowed.\n  * Mean QTcF \\>480 ms (the electrocardiogram can be repeated at the discretion of the investigator).\n  * Cardiac troponin I or T \\>2 × upper limit normal.\n* Have serious or non-healing wounds, ulcers, or (incompletely healed) bone fracture. This includes history (within 6 months before starting the study treatment) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation\u002Ffistula and\u002For the underlying process causing the fistula\u002Fperforation.\n* Have significant risk of hemorrhage (in the opinion of the investigator) or evidence of major coagulation disorders.\n* Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). However, participants who are clinically stable following treatment for these conditions (including therapeutic thoracentesis or paracentesis or with indwelling catheters, e.g., PleurX) are allowed.\n* Have adverse events from prior antitumor therapy that have not returned to Grade 1 (graded by CTCAE v5.0 criteria) or below (unless the investigator determines that certain adverse events pose no safety risk to participants, such as hair loss or stable hypothyroidism under hormone replacement therapy).\n* Active colitis, including infectious, radioactive, ischemic enteritis, within 4 weeks before starting the study treatment.\n* History of serious allergic diseases, history of serious allergy to drugs (including unlisted investigational drug) or known allergy or intolerance to any ingredient of the study treatment.\n* Uncontrolled seizures after best medical therapy or other neurological conditions including clinically significant autoimmune neurological disorders which can increase risk for adverse effects or confound assessment of study outcomes as determined by the investigator.\n* Have superior vena cava syndrome or symptoms of spinal cord compression.\n* Have active, or a history of, pneumonitis requiring treatment with steroids, or have active or a history of interstitial lung disease.\n* Have a known history of tuberculosis that was not successfully treated.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.","75 Years",{"count":484,"type":22},75,[56],"This multi-site Phase II study will enroll adults with histologically confirmed diagnosis of World Health Organization (WHO) Grade IV glioblastoma (GBM), isocitrate dehydrogenase (IDH)-wildtype consistent with WHO central nervous system (CNS) 2021 criteria who have received prior first-line treatment including with at least radiotherapy and temozolomide, with a Karnofsky performance status (KPS) ≥60, adequate organ function, and at least one measurable lesion according to the response assessment in neuro-oncology (RANO) 2.0 criteria.",[488],"Recurrent Glioblastoma",[65,66,96,490,63,491],"Brain tumor","Vascular endothelial growth factor(-A) (VEGF-A)","2026-04-28",{"date":466,"type":38},{"date":495,"type":38},"2026-01-15",{"date":497,"type":22},"2029-07",{"name":44,"class":45},{"id":500,"slug":501,"hasResults":11,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":509,"conditions":510,"keywords":512,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":519,"locationsCount":452},"100612578","phase-2-a-clinical-trial-testing-the-safety-of-bnt327-an-investigational-drug-and-how-well-it-works-when-combined-with-chemotherapy-for-people-who-have-not-been-treated-yet-for-pancreatic-cancer-100612578","NCT07255404","A Clinical Trial Testing the Safety of BNT327 (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer","A Phase II, Multi-site, Randomized, Open-label, Trial of BNT327 in Combination With Chemotherapy in Patients With Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n* Have a histologically or cytologically confirmed metastatic PDAC. A tissue sample, archival or fresh, must be provided during the screening period. In case it is not feasible to meet the required tumor tissue criteria, approval by the sponsor's medical monitor is needed for enrollment.\n* Have not received prior systemic therapy for unresectable metastatic PDAC. For participants who have received prior induction chemotherapy, concurrent chemoradiotherapy, or adjuvant\u002Fneoadjuvant chemotherapy for curative-intent, the interval should be at least 6 months from the end of the last treatment to relapse.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures) are not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system \\[CNS\\] metastasis should not be considered as a measurable lesion).\n* Agree to discontinue strong inhibitors or inducers of cytochrome P450 enzyme (CYP3A), CYP2C8, glucuronosyltransferase 1 family, polypeptide A cluster 1A (UGT1A1) at least 2 weeks prior to starting study treatment, and change to other treatment regimens at screening if such drugs are used.\n\nExclusion Criteria:\n\n* Have received any of the following therapies or drugs before study enrollment:\n\n  * Have received prior systemic anticancer therapy for unresectable metastasis disease.\n  * Any anticancer therapy, including systemic, palliative, biologic, immunostimulatory, or immunosuppressive treatment within 4 weeks (or five half-lives, whichever is longer) before starting study treatment.\n  * PD(L)-1\u002FVEGF bispecific antibody, including monotherapy with either category or combinations thereof.\n  * Systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 14 days before starting study treatment. Exception: Excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergies) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).\n  * Vaccinations with live attenuated vaccine(s) within 4 weeks before starting study treatment.\n  * Broad-spectrum intravenous antibiotics therapy within 2 weeks before starting study treatment.\n  * Any non-study investigational medicinal product within five half-lives of the first dose or within 4 weeks, whichever is longer, before initiation of study treatment in this study or ongoing participation in the active treatment phase of another interventional clinical study.\n  * Antiplatelet drugs, such as aspirin (\\>325 mg\u002Fday), clopidogrel (\\>75 mg\u002Fday), dipyridamole, ticlopidine or cilostazol, etc., within 10 days before starting study treatment to avoid inclusion of participants who have used platelet aggregation inhibitors before the study.\n* Have undergone major organ surgery (core needle biopsies are allowed \\>7 days before starting study treatment), open biopsy, significant trauma, or invasive dental procedures (such as dental implants) within 28 days before starting study treatment, or a planned\u002Fanticipated need for major surgery during the study treatment period. Placement of vascular infusion devices is allowed. Note: If participant has had major surgery, they must have recovered adequately from the toxicity and\u002For complications from the treatment before starting study treatment.\n* Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.\n* Have spinal cord compression or CNS metastases that are untreated and symptomatic or require treatment with corticosteroids or anticonvulsants for associated-symptom control. Exception: Treated brain metastases which are no longer symptomatic and for which no corticosteroid or anticonvulsant treatment is needed (the participant must have recovered from the acute toxic effect of radiotherapy).\n* Have active autoimmune disease or history of autoimmune diseases with anticipated relapse (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for those with clinically stable autoimmune thyroid disease or type 1 diabetes mellitus.\n* Have had other malignant tumors within 5 years before starting study treatment. Exception: Those who have been cured with local treatment (such as basal cell or squamous-cell carcinoma of the skin, superficial or noninvasive bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of thyroid and early-stage prostate cancer).\n* Have heart conditions as specified in the protocol within 6 months before starting study treatment.\n* Have uncontrolled hypertension or poorly controlled diabetic conditions as specified in the protocol before starting study treatment.\n* History of myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months before starting study treatment.\n* History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (e.g., inferior vena cava filter placed) and\u002For adequately anticoagulated on a prophylactic dose.\n* Have serious or non-healing wounds, ulcers, or (incompletely healed) bone fractures. This includes history (within 6 months before starting the study treatment) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation\u002Ffistula and\u002For the underlying process causing the fistula\u002Fperforation.\n* Have significant risk of hemorrhage (in the opinion of the investigator) or evidence of major coagulation disorders as specified in the protocol.\n* Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Those with indwelling catheters (e.g., PleurX) are allowed.\n* Participants with a history of serious Grade 3 or higher immune-related adverse events (irAEs) that led to treatment discontinuation of a prior immunotherapy. Participants with a history of Grade 3 or higher irAEs that did not lead to treatment discontinuation of a prior immunotherapy may be enrolled at the investigator's discretion.\n* Have adverse events (AEs) from prior antitumor therapy that have not returned to Grade 1 (graded by CTCAE v5.0 criteria) or below (unless the investigator determines that certain AEs pose no safety risk to participants, such as hair loss, Grade 2 peripheral neuropathy or stable hypothyroidism under hormone replacement therapy).\n* Have gastrointestinal symptoms or conditions as specified in the protocol.\n* History of serious allergic diseases, history of serious allergy to drugs (including unlisted investigational drug) or known allergy or intolerance to any ingredient of the study treatment.\n* Have superior vena cava syndrome or symptoms of spinal cord compression.\n* Have active, or a history of, pneumonitis requiring treatment with steroids, or have active or a history of interstitial lung disease. Those with a history of pulmonary fibrosis or with currently diagnosed severe lung diseases such as interstitial pneumonia, pneumoconiosis, chemical pneumonitis, or any other condition resulting in significant impairment in lung function. Exception: Asymptomatic interstitial changes caused by previous radiotherapy, chemotherapy, or other factors such as smoking are allowed.\n* Have a known history of tuberculosis that was not successfully treated.\n* Have active syphilis. Participants with inactive previous infection could be eligible: Infection with a positive non-specific antibody test for syphilis (e.g., TRUST \\[Toluidine Red Unheated Serum Test\\], Rapid Plasma Reagin \\[RPR\\], TP-PA \\[Treponema pallidum Particle Agglutination\\]) or have a positive syphilis-specific antibody test (e.g., TPPA) (a positive \"syphilis-specific antibody test\" but a negative \"non-specific antibody test for syphilis\" for more than 1 year) infection.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":507,"type":22},105,[56],"This study will enroll adults with confirmed metastatic pancreatic ductal adenocarcinoma (PDAC, systemic PDAC treatment naïve), Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, and adequate organ function. Participants will receive pumitamig (BNT327) in combination with chemotherapy.",[511],"Pancreatic Ductal Adenocarcinoma (PDAC)",[513,65,514,66,96,63,491],"PDAC","Metastatic pancreatic cancer",{"date":466,"type":38},{"date":517,"type":38},"2025-12-04",{"date":327,"type":22},{"name":44,"class":45},{"id":521,"slug":522,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":23,"phases":529,"briefSummary":530,"conditions":531,"keywords":532,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":542},"100580727","phase-2-safety-and-preliminary-efficacy-of-pumitamig-bnt327-an-investigational-therapy-for-patients-with-non-small-cell-lung-cancer-in-combination-with-chemotherapy-as-first-line-or-second-line-treatment-100580727","NCT06841055","Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment","A Phase II, Multisite, Open-label Trial of Pumitamig (BNT327) in Combination With Standard-of-care Chemotherapy in First-line and Second-line Non-small Cell Lung Cancer (NSCLC)","Key Inclusion Criteria:\n\n* Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that has documented radiographic progression on one or after one prior line of systemic treatment (programmed death-1 \\[PD-1\\]\u002F programmed death ligand-1 \\[PD-L1\\] inhibitor and platinum-based chemotherapy concomitantly) in advanced\u002Fmetastatic setting per the American Joint Committee on Cancer staging system, 9th edition.\n\n  * Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this study.\n  * Only one prior line of immunotherapy containing regimen is allowed in an advanced\u002Fmetastatic setting. If participant had received adjuvant immunotherapy the disease-free interval (after the last dose of adjuvant immunotherapy) should be at least 6 months.\n  * Historical PD-L1 results must be available.\n  * Participants with actionable genetic alterations may be enrolled if they received locally approved and available targeted agent in combination with immunotherapy in first-line advanced\u002Fmetastatic setting.\n  * Enrollment of participants with primary resistance (best response being radiological progression to prior immunochemotherapy) will be kept below 30% in the overall study population.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been documented after irradiation. Historical images within 28 days of the screening visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator.\n* Participants must provide tumor tissue samples obtained ≤18 months prior to enrollment. For the additional cohort in Part 2, both baseline (freshly obtained) and on-treatment tumor biopsy samples are required.\n* Eastern cooperative oncology group performance status of 0 or 1.\n* Adequate organ function as defined in the protocol.\n\nKey Exclusion Criteria:\n\n* Have a known or suspected hypersensitivity to the study treatments, their metabolites or formulation of excipients including polysorbate 80 (see Docetaxel label).\n* Participants who received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-PD-(L)-1\u002FaVEGF bispecific antibody or docetaxel as monotherapy or in combination with other agents.\n* Have received more than one prior lines of therapies in advanced\u002Fmetastatic setting.\n* Have received systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment (except for docetaxel premedication). Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.\n* Participants who have received prior radiotherapy may be enrolled if they have no acute toxicity related to this therapy.\n* Have uncontrolled hypertension or poorly controlled diabetic conditions within 7 days prior to the first dose of study treatment.\n* Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation\u002Ffistula and\u002For the underlying process causing the fistula\u002Fperforation.\n* Participants with significant risk of hemorrhage as defined in the protocol.\n* Have superior vena cava syndrome or symptoms of spinal cord compression.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":528,"type":22},60,[56],"This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced\u002Fmetastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care.\n\nPart 1 is a safety run-in with pumitamig (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants in total to be treated in Part 1A and 1B sequentially.\n\nPart 2 is a dose expansion at the deemed safe dose of pumitamig plus docetaxel and will include up to 54 participants.",[126],[533,66,99,65,98,63,129],"Second-line treatment","2026-04-23",{"date":536,"type":38},"2026-04-24",{"date":538,"type":38},"2025-03-03",{"date":540,"type":22},"2028-10",{"name":44,"class":45},30,{"id":544,"slug":545,"hasResults":11,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":557,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":576},"100450184","phase-1-clinical-trial-evaluating-the-safety-tolerability-and-preliminary-efficacy-of-bnt116-alone-and-in-combinations-in-patients-with-advanced-non-small-cell-lung-cancer-100450184","NCT05142189","Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer","LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer","LuCa-MERIT-1","Key Inclusion Criteria:\n\n* Participants must have histologically confirmed NSCLC and measurable disease by RECIST v1.1. Note: Participants in Cohorts 1, 5 and 11 do not have to present with measurable disease.\n\n  1. Participants must present with unresectable Stage III or metastatic Stage IV NSCLC by American Joint Commission on Cancer (AJCC) Cancer Staging Manual, Eighth Edition.\n\n     EXCEPT\n  2. Participants in Cohorts 5 and 11 must present with unresectable Stage III NSCLC by AJCC Cancer Staging Manual, Eighth Edition before receiving pre-study chemoradiotherapy.\n  3. Participants in Cohort 6 with the initial diagnosis of resectable Stage II and Stage III NSCLC by AJCC Cancer Staging Manual, Eighth Edition.\n* Participants in Cohorts 2, 4, 5, 6, 10 and 11 must be able to tolerate (additional) anti-PD-1 therapy (i.e., did not permanently discontinue anti-programmed death protein 1 \\[PD-1\\] \u002F programmed death ligand 1 \\[PD-L1\\] therapy due to toxicity).\n* Participants must have an Eastern Cooperative Oncology Group performance status (ECOG-PS) less than or equal to (\\\u003C=) 1, except for participants in Cohorts 1, 4, 5, 10 and 11 who are eligible with an ECOG-PS of 0-2.\n\nCohort-specific inclusion criteria:\n\nCohort 1:\n\n* Participants' prior therapy must have included at least a PD-1\u002FPD-L1 inhibitor and a platinum-based chemotherapy regimen as well as one other line of systemic therapy (except if a participant is not candidate for a platinum-based chemotherapy and\u002For PD-1\u002FPD-L1 inhibitor and\u002For another line of systemic therapy). Note: Participants newly enrolled in Cohort 1B under protocol v 5.0 and subsequent versions of the protocol must consent to mandatory blood sampling for peripheral blood mononuclear cells (PBMCs).\n* Participants who are to start cemiplimab at Cycle 3 must present with PD-L1 expression of tumor proportion score (TPS) greater than or equal to (\\>=) 1% in tumor cells (as determined locally).\n\nCohort 2:\n\n* Participants must present with PD-L1 expression of tumor proportion score (TPS) \\>= 50% in tumor cells (as determined locally prior to inclusion in this study).\n* Participants must present with progressive disease either\n\n  1. in the advanced or metastasized stage of NSCLC: while on a PD-1\u002FPD-L1 inhibitor therapy or within 6 months of termination of this treatment as first-line treatment. Or\n  2. be refractory to ongoing adjuvant therapy\u002Fmaintenance treatment after CRT with a PD-1\u002FPD-L1 inhibitor that has been given for at least 3 months in monotherapy (i.e., after an initial combination therapy) before being enrolled into this study.\n\nCohort 3:\n\n* Participants' prior therapy must have included at least a PD-1\u002FPD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a participant is not candidate for a platinum-based chemotherapy and\u002For PD-1\u002FPD-L1 inhibitor).\n* Participants must present with progressive disease.\n\nCohort 4:\n\n* Participants who are not candidates for chemotherapy as first-line treatment for the advanced or metastasized stage of NSCLC may be enrolled if presenting with PD-L1 expression: TPS \\>= 1% in tumor cells (as determined locally).\n\nCohort 5:\n\n* Participants' NSCLC must have been considered unresectable due to participant's condition and\u002For tumor-related factors and the participants must have undergone chemoradiotherapy before entering the study.\n\nCohort 6:\n\n* Participants' NSCLC must be considered technically and medically resectable.\n* Participants must be considered eligible for neo-adjuvant treatment.\n\nCohort 7:\n\n* Participants' prior therapy must have included at least a PD-1\u002FPD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a participant is not a candidate for a platinum-based chemotherapy and\u002For PD-1\u002FPD-L1 inhibitor). Note 1: Participants may have received prior therapy targeting CTLA-4, lymphocyte-activation gene 3 (LAG-3), T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif \\[ITIM\\] domain (TIGIT), VEGF or VEGF receptor (VEGFR) inhibitor as monotherapy or part of a combination therapy. Note 2: If the participants' prior therapies included a CTLA-4 inhibitor, the participant must be able to tolerate (additional) treatment with the CTLA-4 inhibitor.\n* Participants must present with progressive disease at study enrollment.\n* Participants must consent to mandatory blood sampling for PBMCs.\n\nCohorts 8 \\& 9:\n\n* Participants' prior therapy must have included at least a PD-1\u002FPD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a participant is not a candidate for a platinum-based chemotherapy and\u002For PD-1\u002FPD-L1 inhibitor).\n* Participants must present with progressive disease at study enrollment.\n\nCohort 10:\n\n* Participants who are not candidates for chemotherapy as first-line treatment for the advanced or metastasized stage of NSCLC may be enrolled.\n\nCohort 11:\n\n* Participants' NSCLC must have been considered unresectable due to participants condition and\u002For tumor related factors and the participants must have undergone chemoradiotherapy before entering the study.\n\nCohort EGFR (will enroll only at selected sites in the US):\n\n* Participants' NSCLC must have classical EGFR mutations, i.e., ex19Del or L858R.\n* Participants must have ongoing treatment with osimertinib.\n\nCohort ALK\u002FRET (will enroll only at selected sites in the US):\n\n* Participants' NSCLC must have ALK rearrangement or RET rearrangement.\n* Participants must have ongoing treatment with a standard of care ALK TKI or RET TKI.\n\nKey Exclusion Criteria:\n\n* Ongoing active systemic treatment against NSCLC.\n* Presence of a driver mutation for which approved target therapies are available except if the participant is not a candidate for the respective targeted therapy. EXCEPT participants in Cohort EGFR and Cohort ALK\u002FRET.\n* Ongoing or recent evidence (within the last 5 years) of significant autoimmune disease that required treatment with systemic immunosuppressive treatments which may suggest risk for immune-related adverse events. Note: Participants with autoimmune-related hyperthyroidism, autoimmune-related hypothyroidism who are in remission, or on a stable dose of thyroid-replacement hormone, vitiligo, or psoriasis may be included.\n* Current evidence of new or growing brain or spinal metastases during screening. Participants with leptomeningeal disease are excluded. Participants with known brain or spinal metastases may be eligible for all Cohorts, except for Cohorts 5, 6 and 11, if they:\n* had radiotherapy or another appropriate therapy for the brain or spinal metastases, AND\n* have no neurological symptoms that can be attributed to the current brain lesions, AND\n* have stable brain or spinal disease on the computed tomography (CT) or magnetic resonance imaging (MRI) scan within 4 weeks before signing the informed consent (confirmed by stable lesions on two scans at least 4 weeks apart), AND\n* do not require steroid therapy for the treatment of brain or spinal metastases within 14 days before the first dose of study treatment. Note: Spinal bone metastases (that is, of the vertebrae) are allowed, unless imminent fracture or cord compression is anticipated.\n* Systemic immune suppression:\n* Current use of chronic systemic steroid medication (\\\u003C= 5 mg\u002Fday prednisolone equivalent is allowed); participants using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible. Note: Steroid medication given for supportive or prophylactic reasons during CRT for participants in Cohorts 5 and 11 needs to be tapered to \\\u003C= 5 mg\u002Fday prednisolone equivalent at latest on the day before the study treatment starts.\n* Other clinically relevant systemic immune suppression within the last 3 months before study enrollment.\n* Known history of seropositivity for human immunodeficiency virus (HIV) with cluster of differentiation 4 (CD4)+ T-cell (CD4+) counts less than (\\\u003C) 350 cells\u002Fmicrolitre (mcL) and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections.\n* Prior splenectomy.\n* History\u002Frisk of interstitial lung disease or low baseline lung function (baseline pulse oximetry of less than 92% oxygen saturation \\[SpO2\\] without additional oxygen).\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply to all or some participants depending on the cohort.",{"count":552,"type":22},320,[25],"This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and\u002For in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \\[CTLA-4\\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor, an anti-human epidermal growth factor receptor 3 (HER3) antibody conjugated to a topoisomerase I inhibitor or a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) in participants with non-small cell lung cancer (NSCLC).\n\nThe study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above.\n\nThe study will enroll participants with NSCLC in advanced or metastatic stage in Cohorts 1 to 4 and Cohorts 7 to 10, unresectable NSCLC Stage III in Cohorts 5 and 11, resectable NSCLC of Stage II and III in Cohort 6, advanced\u002Fmetastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced\u002Fmetastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK\u002FRET.\n\nCohort EGFR and Cohort ALK\u002FRET will enroll only at selected sites in the US.",[556],"Non-Small Cell Lung Cancer",[558,556,129,99,559,560,66,186,561,562,563,564,565,566,567],"Cancer Vaccine","anti-B7-H3 antibody conjugated to topoisomerase I inhibitor","anti-HER3 antibody conjugated to topoisomerase I inhibitor","Anaplastic lymphoma kinase (ALK) rearranged Non-Small Cell Lung Cancer","Rearranged during transfection (RET) rearranged Non-Small Cell Lung Cancer","NSCLC","anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody","Epidermal growth factor receptor (EGFR)-mutant Non-Small Cell Lung Cancer","Combination with a programmed cell death protein 1 (PD-1) inhibitor","Human epidermal growth factor receptor 3","2026-04-09",{"date":570,"type":38},"2026-04-14",{"date":572,"type":38},"2022-06-17",{"date":574,"type":22},"2031-11",{"name":44,"class":45},44,{"id":578,"slug":579,"hasResults":11,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":584,"enrollmentInfo":585,"targetDuration":4,"studyType":23,"phases":587,"briefSummary":588,"conditions":589,"keywords":593,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":603,"locationsCount":303},"100622127","phase-2-a-randomized-clinical-trial-investigating-the-safety-reactogenicity-and-immunogenicity-after-immunization-with-an-mrna-based-mpox-vaccine-candidate-in-africa-100622127","NCT07379580","A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa","Safety, Reactogenicity, and Immunogenicity of an Mpox mRNA Vaccine Candidate, BNT166a, in Healthy Participants Aged 18 Years and Older in African Countries: A Randomized, Double-blind, Placebo-controlled Phase II Trial","Key Inclusion Criteria (applicable to all participants unless otherwise specified):\n\n* Are male or female individuals ≥18 years of age at the time of giving informed consent:\n\n  * Cohort 1: ≥18 to ≤45 years of age\n  * Cohort 2: ≥18 to ≤64 years of age\n* Cohort 1: Participants must be Orthopoxvirus-naïve (have no history of smallpox or mpox vaccination or mpox infection).\n* Cohort 2: Participants must be Orthopoxvirus-experienced (have evidence of mpox or smallpox vaccination or mpox infection at least 2 years prior to consent).\n\nKey Exclusion Criteria (applicable to all participants unless otherwise specified):\n\n* Have had recent exposure to mpox (defined as close contact with a probable or confirmed case of mpox within the past 28 days, or have evidence of mpox infection or mpox vaccination within 2 years prior to consent).\n* Have a contraindication, warning and\u002For precaution to vaccination with a messenger ribonucleic acid (mRNA) Coronavirus disease 2019 (COVID-19) vaccine as specified in the Summary of Product Characteristics for BNT162b2 (COMIRNATY United States Prescribing Information\u002FEuropean Union Summary of Product Characteristics) and BNT166 Investigator Brochure.\n* Have a history of allergies, hypersensitivities, or intolerance to the study treatments including any excipients thereof.\n* Have a current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias.\n* Have any known bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.\n* Have a body mass index ≤18.5 kg\u002Fm\\^2 or ≥35 kg\u002Fm\\^2.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.","64 Years",{"count":586,"type":22},310,[56],"This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.",[590,591,592],"Mpox (Monkeypox)","Smallpox","Orthopoxvirus Infection",[594,595,596],"Monkeypox virus (MPXV)","Active immunization","Ribonucleic acid (RNA) vaccine","2026-03-02",{"date":599,"type":38},"2026-03-04",{"date":601,"type":38},"2026-02-20",{"date":301,"type":22},{"name":44,"class":45},{"id":605,"slug":606,"hasResults":11,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":23,"phases":613,"briefSummary":614,"conditions":615,"keywords":616,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":626},"100573738","phase-1-safety-and-preliminary-effectiveness-of-bnt317-an-investigational-therapy-for-advanced-solid-tumors-100573738","NCT06750185","Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors","A Phase I, First-in-human, Open-label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Patients With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Have histologically or cytologically confirmed advanced tumors, who have failed standard therapy, or for whom no standard treatment option is available, or for whom standard therapy is not appropriate.\n* Have at least one measurable lesion based on RECIST 1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system \\[CNS\\] metastasis should not be considered as a measurable lesion).\n* Adequate hematologic and organ function.\n\nKey Exclusion Criteria:\n\n* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:\n\n  * Any prior treatment which inhibits cluster of differentiation 39 (CD39).\n  * Vaccination with live attenuated vaccine(s) within 4 weeks prior to the first dose of IMP.\n  * Any investigational product within 4 weeks or 5 half lives (if the half life of the other investigational product is known), whichever is longer, before the first dose of IMP in this study or ongoing participation in the active treatment phase of another interventional clinical study.\n  * Systemic cytotoxic chemotherapy, immunotherapy within 3 weeks or five half-lives of the chemotherapy (whichever is shorter) prior to the first dose of IMP.\n  * Radiation therapy (chest, brain or internal organs) within 4 weeks prior to the first dose of IMP.\n  * Palliative radiotherapy to metastasis within 2 weeks prior to the first dose of IMP.\n  * Systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 2 weeks prior to the first dose of IMP. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) is allowed.\n* Have any of the following CNS metastases:\n\n  * Untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).\n  * Treated CNS metastases who are not neurologically stable or on steroids or anticonvulsants within 2 weeks before initiating IMP of this study.\n  * Brain metastases treated with radiotherapy that are not confirmed stable by magnetic resonance imaging or contrast-enhanced computer tomography 4 weeks after radiotherapy.\n  * Participants with known leptomeningeal metastases.\n* Have uncontrolled hypertension or poorly controlled diabetes as specified in the protocol.\n* Have a history of allogeneic hematopoietic stem cell transplantation or organ transplantation.\n* Have a history of serious Grade ≥3 immune-related adverse events (irAEs) or irAEs that led to discontinuation of a prior immunotherapy. Participants with a history of Grade ≥3 irAEs that did not lead to discontinuation of a prior immunotherapy may be included at the discretion of the investigator. If required by the investigator, after consultation with the sponsor.\n* Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":612,"type":22},39,[25],"This is a first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.",[316],[617,66],"Malignant solid tumors","2026-02-10",{"date":620,"type":38},"2026-02-11",{"date":622,"type":38},"2025-01-13",{"date":624,"type":22},"2028-06",{"name":44,"class":45},11,""]