protocolSection identificationModule nctId: NCT06265727, orgStudyIdInfo id: CRB-701-01, briefTitle: A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-01-16, completionDateStruct date: 2027-01-27, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Corbus Pharmaceuticals Inc., class: INDUSTRY, collaborators name: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., descriptionModule briefSummary: 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.The main questions it aims to answer are:What is the the safe and effective dose of CRB-701 when used alone? What cancers can be treated effectively with CRB-701?Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701 on its own. They will have blood tests and other assessments to measure whether CRB-701 will have CT or MRI scans to measure the effect on tumors., conditionsModule conditions: Solid Tumor, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: A three part study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: CRB-701, outcomesModule primaryOutcomes measure: Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701, primaryOutcomes measure: Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR), primaryOutcomes measure: Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR), secondaryOutcomes measure: Parts A, B, % C: To characterize the safety profile of CRB-701, secondaryOutcomes measure: Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax), secondaryOutcomes measure: Maximum observed plasma concentration of free MMAE (Cmax), secondaryOutcomes measure: Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax), secondaryOutcomes measure: Time to reach Cmax of Total CRB-701 [Total ADC] (Tmax), secondaryOutcomes measure: Time to reach Cmax of free MMAE (Tmax), secondaryOutcomes measure: Time to reach Cmax of Total CRB-701 antibody [Tab] (Tmax), secondaryOutcomes measure: Time to reach Cmax of Total CRB-701 antibody [Tab] (Cmax), secondaryOutcomes measure: Total Area Under the plasma concentration-time curve of Total CRB-701 [total ADC] (AUC), secondaryOutcomes measure: Total Area Under the plasma concentration-time curve of free MMAE (AUC), secondaryOutcomes measure: Total Area Under the plasma concentration-time curve of Total CRB-701 antibody [Tab] (AUC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Moores Cancer Centre at UC San Diego Health, status: NOT_YET_RECRUITING, city: San Diego, state: California, zip: 92037, country: United States, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Helen Diller Family Comprehensive Cancer Center - UCSF, status: NOT_YET_RECRUITING, city: San Francisco, state: California, zip: 94115, country: United States, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Rocky Mountain Cancer Centres, status: NOT_YET_RECRUITING, city: Denver, state: Colorado, zip: 80218, country: United States, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Yale Cancer Center, status: NOT_YET_RECRUITING, city: New Haven, state: Connecticut, zip: 06510, country: United States, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Florida Cancer Specialists, status: NOT_YET_RECRUITING, city: Orlando, state: Florida, zip: 32806, country: United States, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 28.53834, lon: -81.37924, locations facility: University of Chicago, status: NOT_YET_RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Hope and Healing Cancer Center, status: RECRUITING, city: Hinsdale, state: Illinois, zip: 60521, country: United States, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 41.80086, lon: -87.93701, locations facility: Dana-Faber Cancer Institute, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Rodney Carter, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Nebraska Hematology Oncology, status: RECRUITING, city: Lincoln, state: Nebraska, zip: 68506, country: United States, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 40.8, lon: -96.66696, locations facility: Carolina BioOncology Institute, status: RECRUITING, city: Huntersville, state: North Carolina, zip: 28078, country: United States, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 35.41069, lon: -80.84285, locations facility: Texas Oncology, status: NOT_YET_RECRUITING, city: Tyler, state: Texas, zip: 75702, country: United States, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 32.35126, lon: -95.30106, locations facility: Virginia Cancer Specialists, status: NOT_YET_RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 38.84622, lon: -77.30637, locations facility: Barcelona IOB Hospital Quironsalud (NEXT), status: NOT_YET_RECRUITING, city: Barcelona, zip: 08023, country: Spain, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Vall d-Hebron Institut d'Oncologia, status: NOT_YET_RECRUITING, city: Barcelona, zip: 08035, country: Spain, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Fundacion Jimenez Diaz (START), status: NOT_YET_RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Clinico Universitario de Valencia, status: NOT_YET_RECRUITING, city: Valencia, zip: 46010, country: Spain, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Adana Numune Egitim ve Arastirma Hastanesi (Adana City Education and Research Hospital), status: NOT_YET_RECRUITING, city: Adana, zip: 83114, country: Turkey, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 37.00167, lon: 35.32889, locations facility: Ankara Etlik City Hospital, status: NOT_YET_RECRUITING, city: Ankara, country: Turkey, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Ankara University, status: NOT_YET_RECRUITING, city: Ankara, country: Turkey, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Istanbul Medeniyet University, status: NOT_YET_RECRUITING, city: Istanbul, zip: 34720, country: Turkey, contacts name: Rodney Carter, role: CONTACT, email: Clincal@corbuspharma.com, geoPoint lat: 41.01384, lon: 28.94966, locations facility: University of Birmingham NHS Foundation Trust, status: NOT_YET_RECRUITING, city: Birmingham, zip: B15 2TH, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 52.48142, lon: -1.89983, locations facility: University of Cambridge NHS Foundation Trust, status: NOT_YET_RECRUITING, city: Cambridge, zip: CB2 0QQ, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 52.2, lon: 0.11667, locations facility: Velindre Cancer Centre, status: NOT_YET_RECRUITING, city: Cardiff, zip: CF15 7QZ, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 51.48, lon: -3.18, locations facility: Leeds University Hospitals NHS Trust, status: NOT_YET_RECRUITING, city: Leeds, zip: LS9 7LP, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 53.79648, lon: -1.54785, locations facility: Guy's and St Thomas' Clinical Research Facility, status: NOT_YET_RECRUITING, city: London, zip: SE1 9RT, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Imperial Experimental Cancer Medicine Centre, status: NOT_YET_RECRUITING, city: London, zip: W12 0NN, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 51.50853, lon: -0.12574, locations facility: The Christie Hospital, status: NOT_YET_RECRUITING, city: Manchester, zip: M20 4BX, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 53.48095, lon: -2.23743, locations facility: University of Southampton, status: NOT_YET_RECRUITING, city: Southampton, zip: SO16 6YD, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 50.90395, lon: -1.40428, locations facility: University of Liverpool - Clatterbridge Medical Centre, status: NOT_YET_RECRUITING, city: Wirral, zip: CH63 4JY, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 53.37616, lon: -3.10501, hasResults: False