A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs

Launched by KRYSTAL BIOTECH, INC. · Jan 18, 2024

Nctid: NCT06228326

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"term"=>"Sarcoma"}, {"id"=>"D000018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D000007680", "term"=>"Kidney Neoplasms"}, {"id"=>"D000014571", "term"=>"Urologic Neoplasms"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007674", "term"=>"Kidney Diseases"}, {"id"=>"D000014570", "term"=>"Urologic Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D000018213", "term"=>"Neoplasms, Bone Tissue"}, {"id"=>"D000009372", "term"=>"Neoplasms, Connective Tissue"}, {"id"=>"D000002283", "term"=>"Carcinoma, Bronchogenic"}, {"id"=>"D000001984", "term"=>"Bronchial Neoplasms"}], "browseLeaves"=>[{"id"=>"M11172", "name"=>"Lung Neoplasms", "asFound"=>"Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "asFound"=>"Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M9613", "name"=>"Carcinoma, Hepatocellular", "relevance"=>"LOW"}, {"id"=>"M5548", "name"=>"Carcinoma, Renal Cell", "asFound"=>"Renal Cell Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M15327", "name"=>"Sarcoma", "relevance"=>"LOW"}, {"id"=>"M15334", "name"=>"Osteosarcoma", "asFound"=>"Osteosarcoma", "relevance"=>"HIGH"}, {"id"=>"M27137", "name"=>"Respiratory Aspiration", "relevance"=>"LOW"}, {"id"=>"M5546", "name"=>"Carcinoma, Non-Small-Cell Lung", "asFound"=>"Lung Cancer, Non-Small Cell", "relevance"=>"HIGH"}, {"id"=>"M28323", "name"=>"Small Cell Lung Carcinoma", "asFound"=>"Lung Cancer, Small Cell", "relevance"=>"HIGH"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M14979", "name"=>"Respiratory Tract Neoplasms", "relevance"=>"LOW"}, {"id"=>"M16658", "name"=>"Thoracic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M20350", "name"=>"Neoplasms, Connective and Soft Tissue", "relevance"=>"LOW"}, {"id"=>"M10703", "name"=>"Kidney Neoplasms", "relevance"=>"LOW"}, {"id"=>"M17320", "name"=>"Urologic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M10698", "name"=>"Kidney Diseases", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M20359", "name"=>"Neoplasms, Bone Tissue", "relevance"=>"LOW"}, {"id"=>"M12317", "name"=>"Neoplasms, Connective Tissue", "relevance"=>"LOW"}, {"id"=>"M5540", "name"=>"Carcinoma, Bronchogenic", "relevance"=>"LOW"}, {"id"=>"M5260", "name"=>"Bronchial Neoplasms", "relevance"=>"LOW"}, {"id"=>"T4906", "name"=>"Renal Cell Carcinoma", "asFound"=>"Renal Cell Carcinoma", "relevance"=>"HIGH"}, {"id"=>"T1341", "name"=>"Clear Cell Renal Cell Carcinoma", "relevance"=>"LOW"}, {"id"=>"T5284", "name"=>"Soft Tissue Sarcoma", "relevance"=>"LOW"}, {"id"=>"T4340", "name"=>"Osteosarcoma", "asFound"=>"Osteosarcoma", "relevance"=>"HIGH"}, {"id"=>"T5271", "name"=>"Small Cell Lung Cancer", "asFound"=>"Lung Cancer, Small Cell", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SEQUENTIAL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>80}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-04-17", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-02", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE)", "timeFrame"=>"up to 36 months", "description"=>"Percentage of subjects with treatment-related AEs as assessed by NCI-CTCAE v5"}], "secondaryOutcomes"=>[{"measure"=>"To evaluate whether the proposed dose ranges include the maximum tolerated dose of KB707 as determined by incidence of dose limiting toxicities (DLTs)", "timeFrame"=>"up to 36 months", "description"=>"Incidence of dose limiting toxicity (DLT) by dose cohorts"}, {"measure"=>"To evaluate the preliminary efficacy of inhaled KB707 as determined by overall response rate (ORR)", "timeFrame"=>"up to 36 months", "description"=>"Percentage of ORR for all participants"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["solid tumors", "cancer", "Krystal Biotech"], "conditions"=>["Lung Cancer, Non-small Cell", "Lung Cancer Metastatic", "Solid Tumor, Adult", "Advanced Cancer", "Lung Cancer, Small Cell", "Metastatic Colorectal Cancer", "Metastatic Renal Cell Carcinoma", "Metastatic Hepatocellular Carcinoma", "Metastatic Sarcoma", "Metastatic Osteosarcoma"]}, "descriptionModule"=>{"briefSummary"=>"The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector that is designed to stimulate an anti-tumor immune response through the production of cytokines delivered to the airways of people with advanced solid tumor malignancies affecting the lungs via nebulization. This Phase 1, open-label, multicenter, dose escalation and expansion study is designed to evaluate the safety and tolerability of KB707 in adults with with advanced solid tumor malignancies affecting the lungs who have progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy. The study will include a dose escalation portion for single agent KB707 using a standard 3+3 design followed by an expansion portion to further evaluate single agent KB707 at a dose determined by preliminary data in the dose escalation phase. Subjects in both the dose escalation and dose expansion cohorts will receive KB707 via nebulization weekly for three weeks, then every three weeks for up to two years until tumor progression, death, unacceptable toxicity, symptomatic deterioration, achievement of maximal response, subject choice, Investigator decision to discontinue treatment, or the Sponsor determines to terminate the study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Key Inclusion Criteria:\n\n* Histologically confirmed diagnosis of advanced solid tumor malignancy affecting the lungs and the individual has progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or there is no standard of care therapy.\n* Age 18 years or older at the time of informed consent\n* Life expectancy \\>12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Have at least one measurable lesion per RECIST v1.1 at Screening\n\nKey Exclusion Criteria:\n\n* Prior oncology therapy (chemotherapy, immunotherapy, biological therapy) or use of an investigational agent or an investigational device within 21 days or 5 half-lives before administration of first dose of KB707, whichever is shorter\n* The subject is pregnant, nursing, or plans to become pregnant during study treatment and through three months after the last dose of KB707\n* Have known history of positive human immunodeficiency virus (HIV 1/2)"}, "identificationModule"=>{"nctId"=>"NCT06228326", "briefTitle"=>"A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Krystal Biotech, Inc."}, "officialTitle"=>"KB707-02: A Phase 1 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs", "orgStudyIdInfo"=>{"id"=>"KB707-02"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Dose Escalation of KB707 Administered via Nebulization", "description"=>"Dose escalation of single-agent KB707 in 3 cohorts in a standard 3+3 design.", "interventionNames"=>["Biological: KB707"]}, {"type"=>"EXPERIMENTAL", "label"=>"Dose Expansion of KB707 Administered via Nebulization", "description"=>"Dose expansion of single-agent KB707 in approximately 60 subjects with advanced solid tumor malignancies affecting the lungs, including approximately 40 subjects with non-small cell lung cancer.", "interventionNames"=>["Biological: KB707"]}], "interventions"=>[{"name"=>"KB707", "type"=>"BIOLOGICAL", "description"=>"Genetically modified herpes simplex type 1 virus", "armGroupLabels"=>["Dose Escalation of KB707 Administered via Nebulization", "Dose Expansion of KB707 Administered via Nebulization"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"85258", "city"=>"Scottsdale", "state"=>"Arizona", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Oncology Clinical Trials Nurse Navigator", "role"=>"CONTACT", "email"=>"clinicaltrials@honorhealth.com", "phone"=>"480-323-1791"}, {"name"=>"Oncology Clinical Trials Nurse Navigator", "role"=>"CONTACT", "phone"=>"833-354-6667"}, {"name"=>"Justin Moser, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"HonorHealth Research Institute", "geoPoint"=>{"lat"=>33.50921, "lon"=>-111.89903}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Yvonne LaFary, RN", "role"=>"CONTACT", "email"=>"ylafary@iu.edu", "phone"=>"317-278-5613"}, {"name"=>"Anne Younger, RN", "role"=>"CONTACT", "email"=>"anefoste@iupui.edu", "phone"=>"(317) 274-0951"}], "facility"=>"IU Simon Comprehensive Cancer Center", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"70121", "city"=>"New Orleans", "state"=>"Louisiana", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Jill Collins, BA, CCRA", "role"=>"CONTACT", "email"=>"jill.collins@ochsner.org", "phone"=>"504-842-2466"}, {"name"=>"Amanda Woolery, RN, BSN", "role"=>"CONTACT", "phone"=>"504-842-0275"}], "facility"=>"Ochsner/MD Anderson Cancer Center", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"44195", "city"=>"Cleveland", "state"=>"Ohio", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Cancer Answer Line", "role"=>"CONTACT", "phone"=>"216-444-7923"}], "facility"=>"Cleveland Clinic", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"15232", "city"=>"Pittsburgh", "state"=>"Pennsylvania", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Julie Urban, PhD", "role"=>"CONTACT", "email"=>"ClinicalResearchServicesHCCIDDC@upmc.edu", "phone"=>"412-623-7396"}], "facility"=>"UPMC Hillman Cancer Center", "geoPoint"=>{"lat"=>40.44062, "lon"=>-79.99589}}, {"zip"=>"37203", "city"=>"Nashville", "state"=>"Tennessee", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Sarah Cannon Research Institute", "role"=>"CONTACT", "email"=>"asksarah@sarahcannon.com", "phone"=>"844-482-4812"}], "facility"=>"Sarah Cannon Research Institute", "geoPoint"=>{"lat"=>36.16589, "lon"=>-86.78444}}, {"zip"=>"79915", "city"=>"El Paso", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Maya Fleyhan", "role"=>"CONTACT", "email"=>"maya.fleyhan@renovatioclinical.com", "phone"=>"713-703-2398"}], "facility"=>"Renovatio Clinical", "geoPoint"=>{"lat"=>31.75872, "lon"=>-106.48693}}, {"zip"=>"77380", "city"=>"The Woodlands", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Maya Fleyhan", "role"=>"CONTACT", "email"=>"maya.fleyhan@renovatioclinical.com", "phone"=>"713-703-2398"}], "facility"=>"Renovatio Clinical", "geoPoint"=>{"lat"=>30.15799, "lon"=>-95.48938}}], "centralContacts"=>[{"name"=>"David Chien, MD", "role"=>"CONTACT", "email"=>"dchien@krystalbio.com", "phone"=>"412-586-5830"}, {"name"=>"Brittani Agostini, RN, CCRC", "role"=>"CONTACT", "email"=>"bagostini@krystalbio.com", "phone"=>"412-586-5830"}], "overallOfficials"=>[{"name"=>"David Chien, MD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Senior Vice President of Clinical Development"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Krystal Biotech, Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}