[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654273":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":43,"armGroups":50,"interventions":61,"overallOfficials":43,"centralContacts":69,"locations":43,"responsibleParty":75,"collaborators":43,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":43,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":43,"enrollmentInfo":86,"targetDuration":43,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":43,"overallStatus":95,"whyStopped":43,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":43},{"fullName":5,"class":6},"Biolojic Design Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":43},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Phase 1 Part A","Number of Participants with Dose Limiting Toxicities (DLTs)","Cycle 1 Day 1 through Cycle 1 Day 21 [approximately 21 days]",{"measure":14,"description":15,"timeFrame":16},"Phase 1 Part A & Part B","Number of Participants with Treatment-emergent Adverse Events (TEAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation","Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator\u002FSponsor [approximately 12 months]",{"measure":14,"description":18,"timeFrame":19},"Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator","Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator\u002FSponsor [up to approximately 12 months])",{"measure":14,"description":21,"timeFrame":22},"Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator","Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator\u002FSponsor [up to approximately 12 months]",[24,26,28,31,33,35,39,41],{"measure":14,"description":25,"timeFrame":19},"Area Under the Concentration Time Curve (AUC) of BD200",{"measure":14,"description":27,"timeFrame":19},"Maximum Observed Plasma Concentration (Cmax) of BD200",{"measure":14,"description":29,"timeFrame":30},"Number of Participants with Anti-drug Antibodies (ADAs) in Blood","Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator\u002FSponsor [up to approximately 12 months]",{"measure":10,"description":32,"timeFrame":30},"ORR per RECIST Version 1.1 as Assessed by Investigator",{"measure":10,"description":34,"timeFrame":19},"DOR per RECIST Version 1.1 as Assessed by Investigator",{"measure":36,"description":37,"timeFrame":38},"Phase 1 Part B","IHC biopsy data of Trop-2 and Nectin 4 Expression","Cycle 1 Day 1 through EOT [up to approximately 12 months]",{"measure":36,"description":40,"timeFrame":19},"Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator",{"measure":36,"description":42,"timeFrame":19},"Overall Survival (OS)",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":43,"primaryPurpose":47,"observationalModel":43,"timePerspective":43,"maskingInfo":48},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":49,"maskingDescription":43,"whoMasked":43},"NONE",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Part A Dose Escalation","EXPERIMENTAL","Participants with advanced or metastatic solid tumors will receive BD200.",[56],"Drug: BD200",{"label":58,"type":53,"description":59,"interventionNames":60},"Part B Dose Expansion","Participants with at least one tumor type will receive BD200.",[56],[62,67],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":43},"DRUG","BD200","Infusion",[52],{"type":63,"name":64,"description":65,"armGroupLabels":68,"otherNames":43},[58],[70],{"name":71,"role":72,"phone":73,"phoneExt":43,"email":74},"Biolojic Design, Ltd.","CONTACT","+972-8-6988048","contact@biolojic.com",{"type":76,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100654273","phase-1-this-clinical-study-is-to-evaluate-the-safety-tolerability-pharmacokinetics-pk-pharmacodynamics-pd-and-preliminary-antitumor-activity-of-bd200-in-participants-with-advanced-or-metastatic-cancer-100654273",false,"NCT07797907","This Clinical Study is to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of BD200 in Participants With Advanced or Metastatic Cancer.","A Phase 1a\u002Fb, First-in-Human Dose Escalation and Dose Expansion Clinical Study of the Dual Targeting Trop-2 and Nectin-4 Multibody Drug Conjugate BD200 in Participants With Select Unresectable Locally Advanced or Metastatic Cancers","Inclusion Criteria:\n\n* Age 18+ years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Participant willing to provide tumor biopsies\n* Measurable disease per RECIST v1.1\n* Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options\n* Satisfy requirements for prior treatments per tumor type as outlined in the protocol\n* Adequate organ function\n* Agree to contraception requirements as outlined in the protocol\n\nExclusion Criteria:\n\n* Any major surgery or traumatic injury prior to enrollment\n* Unhealed wounds from surgery or injury\n* Received other therapies within 4 weeks prior to enrollment\n* Any clinically significant chronic gastrointestinal (GI) disorder\n* Any clinically significant ascites or liver disease\n* Any clinically significant pulmonary compromise\n* Active infection at the time enrollment\n* Active autoimmune disease\n* History or active skin disease requiring frequent treatment\n* Any clinically significant corneal disorder\n* Active known second malignancy\n* Any clinically significant cardiac disease\n* Participants with tumor abutting or eroding a major vessel\n* Pregnant or lactating or planning to become pregnant\n* Known hypersensitivity to BD200 or any of its ingredients\n* Unresolved toxicities from previous anticancer therapy\n* Participation in a concurrent clinical study in the treatment period\n* Part A Only: Participant with hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV) infection\n\nNote: Other inclusion and exclusion criteria may apply.","ALL","18 Years",{"count":87,"type":88},110,"ESTIMATED","INTERVENTIONAL",[91],"PHASE1","The Phase 1 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of BD200 in adult participants with advanced solid cancers. This is an open-label study consisting of two-parts: Part A Dose Escalation and Part B Dose Expansion. At least one tumor-specific cohort will be selected in Part B Dose Expansion.",[94],"Solid Tumor (Phase I)","NOT_YET_RECRUITING","2026-08-27",{"date":98,"type":99},"2026-09-01","ACTUAL",{"date":101,"type":88},"2026-12-31",{"date":103,"type":88},"2030-12-31",{"name":5,"class":6}]