[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Corbus Pharmaceuticals Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":97},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100652056","phase-3-a-randomized-multicentre-study-to-evaluate-crb-701-compared-to-investigators-choice-therapy-in-previously-treated-oropharyngeal-squamous-cell-carcinoma-100652056",false,"NCT07768189","A Study to Evaluate CRB-701 Compared to Investigator's Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma","A Randomized, 2-Arm Study to Evaluate the Efficacy and Safety of CRB-701 Compared With Investigator's Choice of Capecitabine, Cetuximab, or Docetaxel in Participants With Recurrent or Metastatic Oropharyngeal Squamous Cell Carcinoma Previously Treated With Platinum-based Chemotherapy and a PD-(L)1 Inhibitor","TEMPO-1","Inclusion Criteria:\n\n* Histological and\u002For cytological confirmed diagnosis of OPSCC arising from tonsils, base of tongue, soft palate and posterior pharyngeal wall, with evidence of metastatic or recurrent disease not amenable to standard therapy with curative intent.\n* Either second or third-line OPSCC patients who have progressed on or after receiving SOC therapy (that must have included platinum chemotherapy and an anti-PD-(L)1 antibody administered sequentially or together) OR received platinum chemotherapy and\u002For anti-PD-(L)1 therapy in the neoadjuvant or adjuvant setting or as part of definitive chemoradiation therapy, provided disease recurrence occurred less than 6 months after completion of the relevant systemic therapy.\n* ECOG PS of 0-1\n* Measurable disease as per RECIST v1.1, with at least one measurable lesion not previously irradiated unless unequivocal progression has been documented after radiation.\n* Life expectancy of greater than 12 weeks at time of enrollment, as per Investigator's assessment.\n\nSigned informed consent\n\nExclusion Criteria:\n\n* Persistent CTCAE Grade \\>1 clinically significant toxicities related to prior antineoplastic therapies, excluding alopecia.\n* Significant active or chronic corneal disorders\n* Pre-existing Grade ≥2 peripheral neuropathy\n* Any other significant co-morbidities, disease, metabolic dysfunction, physical examination, or clinical laboratory finding that contraindicates the use of the investigational drug or may represent an unacceptable risk from treatment complications or may affect adherence to the study procedures or the interpretation of the results.\n* Pregnant or breastfeeding females","ALL","18 Years",{"count":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this study is to understand whether CRB-701, a targeted form of chemotherapy called an anti-body drug conjugate, will work as a treatment for oropharyngeal (throat, tonsil) cancer. In patients who have already received platinum based chemotherapy or immunotherapy (using a check-point inhibitor) It will also learn about the safety of the drug and measure quality of life. The main questions it asks are:\n\n* What proportion of participants respond to CRB-701 measured using scans (CT or MRI)\n* What medical problems do participants experience when taking CRB-701.\n\nResearchers will compare CRB-701 with standard of care medicines (drugs that are normally used this disease).\n\nParticipants will:\n\n* Attend clinic every three weeks to receive infusions of CRB-701 or standard of care medicines until the cancer cannot be measured or is not controlled by the treatment they are receiving.\n* Have a CT or MRI every 6 weeks to measure the effect on their cancer\n* Complete questionnaires to assess their health status.",[27],"Oropharyngeal Carcinoma (OPC)",[29,30,31,32,33,34],"Antibody Drug Conjugate","Nectin-4","Oropharyngeal Squamous Cell Carcinoma","HPV-ve","HPV+ve","Head and Neck Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-08-18",{"date":38,"type":39},"2026-08-20","ACTUAL",{"date":41,"type":21},"2026-09-20",{"date":43,"type":21},"2029-03",{"name":45,"class":46},"Corbus Pharmaceuticals Inc.","INDUSTRY",27,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100536507","phase-1-a-phase-12-study-to-investigate-crb-701-in-solid-tumors-100536507","NCT06265727","A Phase 1\u002F2 Study to Investigate CRB-701 in Solid Tumors","A Phase 1\u002F2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed having exhausted all appropriate lines of therapy or have no other standard therapy with proven clinical benefit. In Part C, HNSCC participants may enroll as first-line therapy.\n\nExclusion Criteria:\n\n* Active of uncontrolled CNS metastases\n* History of solid tumors other than the diseases under study\n* History of and\u002For current cardiovascular events or conditions in the previous 6 months\n* Pre-existing \\>\u002F= Grade 2 neuropathy\n* Hemoglobin A1C (HbA1C) \\>\u002F= 8%, uncontrolled diabetes mellitus or know diabetic neuropathy\n* Active ocular disease at baseline\n* Chronic severe liver disease or live cirrhosis\n* Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study\n* Other significant cormorbidities.",{"count":56,"type":21},348,[58,59],"PHASE1","PHASE2","The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4.\n\nThe main questions it aims to answer are:\n\nWhat is the the safe and effective dose of CRB-701? What cancers can be treated effectively with CRB-701?\n\nParticipants will be asked to attend clinic and be given a intravenous infusion of CRB-701. They will have blood tests, CT or MRI Scans, and other assessments to measure whether CRB-701 has an effect on tumors.",[62],"Solid Tumor, Adult",[64],"nectin-4","RECRUITING","2026-01-07",{"date":68,"type":39},"2026-01-08",{"date":70,"type":39},"2024-04-01",{"date":72,"type":21},"2027-01-27",{"name":45,"class":46},41,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100562490","phase-1-first-in-human-study-of-crb-601-01-to-treat-patients-with-advanced-solid-tumor-100562490","NCT06603844","First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.","A Phase 1\u002F2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of CRB-601, a Monoclonal Antibody Against Integrin avb8, in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Confirmed diagnosis of select locally advanced or metastatic solid tumors that have progressed after at least one line of therapy or have no other standard therapy with proven clinical benefit available.\n* Measurable disease on imaging as assessed by RECIST 1.1 Eastern Cooperative Oncology Group (ECOG) performance status (PS) greater or equal to 2.\n* Life expectancy of more than 12 weeks.\n* Adequate hematologic and end-organ function.\n\nExclusion Criteria:\n\n* History of solid tumor malignancies other than the disease under study within 3 years of study enrollment\n* History of and\u002For current cardiovascular events or conditions\n* Chronic severe liver disease or liver cirrhosis\n* Systemic autoimmune disease\n* Active thrombophlebitis, thromboembolism or hypercoagulability states or uncontrolled bleeding or diabetes.\n* Interstitial lung disease within 6 months of study enrollment.\n* Active or persistent infection\n* Other conditions that in the opinion of the Investigator would compromise the outcomes of the study.",{"count":83,"type":21},156,[58,59],"The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy in patients who have advanced solid tumors (cancer) and have exhausted other therapeutic options.CRB-601 targets a protein called avb8 integrin which is expressed by some cancers and not others. This study will focus on tumor types which are know to highly or moderately express this protein.\n\nResearchers will evaluate the side effects caused by treatment, levels of CRB-601 in the blood, and the effect on the participant cancer. This will help researchers understand the right dose of CRB-601 to use for treatment and whether it is an effective treatment to combine with standard of care treatments such as immunotherapy. It will also help the researchers understand whether combining CRB-601 with standard-of-care immunotherapy and immune-priming radiotherapy is a safe and effective approach to treat cancer.\n\nParticipants in the study will receive CRB-601 via an infusion every two weeks either alone or in combination with immunotherapy.\n\nThere will be assessments to check on the participants general health status (including blood tests) and adverse effects. Participants will also receive regular CT or MRI scans to evaluate the effect of CRB-601 on their cancer. Participants will continue to visit the clinic every two weeks while they are receiving benefit from treatment. If their cancer progresses, participants will be asked to continue to be followed-up by the researchers to understand long-term outcomes, even if they receive other treatments.",[87],"Solid Tumor","2025-05-29",{"date":90,"type":39},"2025-06-03",{"date":92,"type":39},"2024-12-04",{"date":94,"type":21},"2026-12-01",{"name":45,"class":46},26,""]